Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374771
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-14
Brief Title:
Analgesic Effect of Melatonin and Vitamin C Administration Alone or In Combination in Major Abdominal Surgery
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Analgesic Effect of Melatonin and Vitamin C Administration Alone or In Combination in Major Abdominal Surgery A Randomized Double-blind Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the analgesic effect of melatonin and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours eg radical cystectomy radical prostatectomy colectomy sigmoidectomy splenectomy and CBD exploration through mid-line incision
This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause
More reduction in total morphine consumption in the first 24 hours postoperatively
More reduction of the incidence of chronic post-surgical pain than using each adjuvant alone
Participants will be allocated into three equal groups Melatonin M group and vitamin C V group and Melatonin and vitamin C VM group Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration 10mg of melatonin for M group Melatonin 10 mg - Puritans Pride premium company 1gm of vitamin C for V group Sanso C 1000 mg - AUG pharma company and 10mg of melatonin and 1gm of vitamin C for VM group
Researchers will compare
The effect of melatonin vitamin C and their combination on postoperative opioid consumption
The severity of postoperative pain using the Numerical Rating Scale NRS
Patients satisfaction with a three-point scale
The time of the first requirement for rescue analgesia
The effect on the incidence of chronic post-surgical pain
This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause
More reduction in total morphine consumption in the first 24 hours postoperatively
More reduction of the incidence of chronic post-surgical pain than using each adjuvant alone
Participants will be allocated into three equal groups Melatonin M group and vitamin C V group and Melatonin and vitamin C VM group Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration 10mg of melatonin for M group Melatonin 10 mg - Puritans Pride premium company 1gm of vitamin C for V group Sanso C 1000 mg - AUG pharma company and 10mg of melatonin and 1gm of vitamin C for VM group
Researchers will compare
The effect of melatonin vitamin C and their combination on postoperative opioid consumption
The severity of postoperative pain using the Numerical Rating Scale NRS
Patients satisfaction with a three-point scale
The time of the first requirement for rescue analgesia
The effect on the incidence of chronic post-surgical pain
Detailed Description:
Randomization will be performed using computer-generated numbers with Random Allocation Software httpsrandom-allocation-softwaresoftwareinformercom20 in a 111 ratio 60 consequentially numbered opaque envelopes 20 per group will be made containing group assignments and drug administration instructions A research assistant will be responsible for opening the envelopes and the assigned drug administration without further involvement in the study A blinded anesthesiologist will be responsible for the anesthetic management perioperative data collection and postoperative pain assessment and analgesia administration
A full history will be taken from all patients Age sex height weight and the American Society of Anesthesiologists ASA score will be recorded
Preoperatively patients laboratory investigations as complete blood count prothrombin time concentration and INR liver function tests and kidney function tests will be recorded Clinical assessment will be carried out for their eligibility for the study
Patients will be allocated into three equal groups Melatonin M group and vitamin C V group and Melatonin and vitamin C VM group Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration 10 10mg of melatonin for M group Melatonin 10 mg - Puritans Pride premium company 1gm of vitamin C for V group Sanso C 1000 mg - AUG pharma company and 10mg of melatonin and 1gm of vitamin C for VM group
The patients will attend the pre-anesthesia room one hour before the procedure NRS pain score Figure 1 will be explained to all candidates zero corresponds to no pain and 10 is indicative of the worst unbearable pain
Baseline vital signs will be then recorded including non-invasive measurements of systolic mean diastolic arterial blood pressures heart rate and oxygen saturation
Anesthetic technique Upon arrival at the operating room standard monitoring non-invasive blood pressure electrocardiography and pulse oximetry will be applied The patient will receive pre-induction ondansetron 8mg as an antiemetic drug Anesthesia will be induced using propofol 1-2 mgkg fentanyl 2 µgkg and lidocaine 1 mgkg Atracurium 05 mgkg will be administered to facilitate endotracheal intubation After intubation the capnography will be connected and the patients will be mechanically ventilated to maintain end-tidal CO2 between 30-35 mmHg Anesthesia will be maintained with sevoflurane inhalational anesthetic in 50 oxygen and top-up doses of atracurium 01mgkg every 20 minutes to maintain muscle relaxation After the skin incision a bolus dose of morphine100mcgkg will be given Fentanyl at 1µgkg will be administered as rescue analgesia if an intraoperative increase in heart rate or systolic blood pressure by 20 occurs after the exclusion of other causes rather than pain Before skin closure paracetamol 1gm will be given intravenously Depth of anesthesia will be monitored by a bispectral index monitoring device BIS to maintain the readings within 40 to 55 all through the procedure Mean blood pressure and heart rate are maintained within 20
Postoperative Technique
Pain will be classified as mild NRS 0-4 moderate NRS 5-7 and severe NRS 8-10 Recovery time is defined as the time from extubation to the time of achieving Aldrete scores 9 The patient is transferred to the post-anesthesia care unit PACU Blood pressure heart rate and oxygen saturation will be monitored every 15 minutes till discharge from the PACU In PACU a bolus dose of morphine the physician will give 50 mcgkg if the pain score of the patient is 4 All patients with a numeric score 4 will receive morphine via an infusion pump Zhejiang Fert disposable infusion pump 275ml with constant flow 5mlhour Zhejiang Fert Medical Device Co Ltd They will receive a morphine continuous infusion of 10mcgkghour maximum 1 mghour The patients will be instructed to report any pain to a pain nurse and if the NRS increases to more than 4 the pain nurse will inform the anesthesiologist Inadequate analgesia NRS 4 will be treated with a clinician bolus of 50mcgkg with a time interval of 30 minutes at least between the additional doses till NRS decreases to less than 4 Excessive somnolence or respiratory depression will be treated by stopping the pump until appropriate recovery and by a decrease in the demand dose of 20 Paracetamol 1gm will be administered every 8 hours intravenously
Postoperative hemodynamics including systolic and diastolic blood pressures SBP and DBP heart rate HR SpO2 NRS Richmond Agitation Sedation Scale RASS and patient satisfaction using Likert three-point scale good moderate and bad scores will be recorded at 2 4 6 12 24 hours The total morphine consumption including the continuous infusion total boluses required and the number of boluses will be recorded at the end of the first 24 hours
The side effects of opioids will be recorded eg nausea vomiting pruritus urine retention and allergic reactions In case of vomiting metoclopramide 10 mg will be given Ondansetron 8mg will be given in persistent vomiting In the case of respiratory depression Naloxone 1mcgkg will be administered and oxygen will be supplied through an oxygen mask
NRS and patient satisfaction using a Likert 3-point scale will be recorded from the patient after 48 72 96 h one month and 3 months post-operative
Three months follow-up phase assessment parameters
Chronic pain assessments will be conducted during patients visits to the pain clinic in the first and third postoperative months by a blinded physician and include the following
1 the location intensity nature and duration of pain as well as any aggravating or mitigating factors
2 Analgesic medication used
3 For cancer patients adjuvant treatment used eg chemotherapy and radiotherapy Chronic Neuropathic pain will be assessed using the Numeric Pain Rating Scale
Data collection
All hemodynamic parameters such as blood pressure using non-invasive measurement heart rate and oxygen saturation will be recorded every 10 minutes from skin incision to skin closure and at 2 4 h postoperatively Other complications such as hypotension nausea and vomiting will be monitored and recorded
Postoperative morphine consumption during the first 24 hours
NRS pain score immediately postoperatively and then at 30 minutes 2 4 6 1224 48 72 96 hours one month and three months NRS will also be recorded when the patient begins to move Dynamic pain will be defined as the difference in NRS score between rest and walking 2 points Pain will be classified as mild NRS 0-4 moderate NRS 5-7 and severe NRS 8-10
RASS score immediately postoperatively and then at 30 minutes 2 4 6 12 and 24 hours
Patients satisfaction Likert three-point scale on the first postoperative day48 73 96 hours one month and three months
Postoperative opioid-related complications eg Nausea vomiting constipation sedation
Anesthesia time starting from induction of anesthesia till extubation of the patient
Surgical operation time starting from skin incision till skin closure
Emergence time is defined as from discontinuation of inhalational anesthesia till the extubation of the patient
Recovery time is defined as the time from extubation to the time of achieving Aldrete scores 9
A full history will be taken from all patients Age sex height weight and the American Society of Anesthesiologists ASA score will be recorded
Preoperatively patients laboratory investigations as complete blood count prothrombin time concentration and INR liver function tests and kidney function tests will be recorded Clinical assessment will be carried out for their eligibility for the study
Patients will be allocated into three equal groups Melatonin M group and vitamin C V group and Melatonin and vitamin C VM group Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration 10 10mg of melatonin for M group Melatonin 10 mg - Puritans Pride premium company 1gm of vitamin C for V group Sanso C 1000 mg - AUG pharma company and 10mg of melatonin and 1gm of vitamin C for VM group
The patients will attend the pre-anesthesia room one hour before the procedure NRS pain score Figure 1 will be explained to all candidates zero corresponds to no pain and 10 is indicative of the worst unbearable pain
Baseline vital signs will be then recorded including non-invasive measurements of systolic mean diastolic arterial blood pressures heart rate and oxygen saturation
Anesthetic technique Upon arrival at the operating room standard monitoring non-invasive blood pressure electrocardiography and pulse oximetry will be applied The patient will receive pre-induction ondansetron 8mg as an antiemetic drug Anesthesia will be induced using propofol 1-2 mgkg fentanyl 2 µgkg and lidocaine 1 mgkg Atracurium 05 mgkg will be administered to facilitate endotracheal intubation After intubation the capnography will be connected and the patients will be mechanically ventilated to maintain end-tidal CO2 between 30-35 mmHg Anesthesia will be maintained with sevoflurane inhalational anesthetic in 50 oxygen and top-up doses of atracurium 01mgkg every 20 minutes to maintain muscle relaxation After the skin incision a bolus dose of morphine100mcgkg will be given Fentanyl at 1µgkg will be administered as rescue analgesia if an intraoperative increase in heart rate or systolic blood pressure by 20 occurs after the exclusion of other causes rather than pain Before skin closure paracetamol 1gm will be given intravenously Depth of anesthesia will be monitored by a bispectral index monitoring device BIS to maintain the readings within 40 to 55 all through the procedure Mean blood pressure and heart rate are maintained within 20
Postoperative Technique
Pain will be classified as mild NRS 0-4 moderate NRS 5-7 and severe NRS 8-10 Recovery time is defined as the time from extubation to the time of achieving Aldrete scores 9 The patient is transferred to the post-anesthesia care unit PACU Blood pressure heart rate and oxygen saturation will be monitored every 15 minutes till discharge from the PACU In PACU a bolus dose of morphine the physician will give 50 mcgkg if the pain score of the patient is 4 All patients with a numeric score 4 will receive morphine via an infusion pump Zhejiang Fert disposable infusion pump 275ml with constant flow 5mlhour Zhejiang Fert Medical Device Co Ltd They will receive a morphine continuous infusion of 10mcgkghour maximum 1 mghour The patients will be instructed to report any pain to a pain nurse and if the NRS increases to more than 4 the pain nurse will inform the anesthesiologist Inadequate analgesia NRS 4 will be treated with a clinician bolus of 50mcgkg with a time interval of 30 minutes at least between the additional doses till NRS decreases to less than 4 Excessive somnolence or respiratory depression will be treated by stopping the pump until appropriate recovery and by a decrease in the demand dose of 20 Paracetamol 1gm will be administered every 8 hours intravenously
Postoperative hemodynamics including systolic and diastolic blood pressures SBP and DBP heart rate HR SpO2 NRS Richmond Agitation Sedation Scale RASS and patient satisfaction using Likert three-point scale good moderate and bad scores will be recorded at 2 4 6 12 24 hours The total morphine consumption including the continuous infusion total boluses required and the number of boluses will be recorded at the end of the first 24 hours
The side effects of opioids will be recorded eg nausea vomiting pruritus urine retention and allergic reactions In case of vomiting metoclopramide 10 mg will be given Ondansetron 8mg will be given in persistent vomiting In the case of respiratory depression Naloxone 1mcgkg will be administered and oxygen will be supplied through an oxygen mask
NRS and patient satisfaction using a Likert 3-point scale will be recorded from the patient after 48 72 96 h one month and 3 months post-operative
Three months follow-up phase assessment parameters
Chronic pain assessments will be conducted during patients visits to the pain clinic in the first and third postoperative months by a blinded physician and include the following
1 the location intensity nature and duration of pain as well as any aggravating or mitigating factors
2 Analgesic medication used
3 For cancer patients adjuvant treatment used eg chemotherapy and radiotherapy Chronic Neuropathic pain will be assessed using the Numeric Pain Rating Scale
Data collection
All hemodynamic parameters such as blood pressure using non-invasive measurement heart rate and oxygen saturation will be recorded every 10 minutes from skin incision to skin closure and at 2 4 h postoperatively Other complications such as hypotension nausea and vomiting will be monitored and recorded
Postoperative morphine consumption during the first 24 hours
NRS pain score immediately postoperatively and then at 30 minutes 2 4 6 1224 48 72 96 hours one month and three months NRS will also be recorded when the patient begins to move Dynamic pain will be defined as the difference in NRS score between rest and walking 2 points Pain will be classified as mild NRS 0-4 moderate NRS 5-7 and severe NRS 8-10
RASS score immediately postoperatively and then at 30 minutes 2 4 6 12 and 24 hours
Patients satisfaction Likert three-point scale on the first postoperative day48 73 96 hours one month and three months
Postoperative opioid-related complications eg Nausea vomiting constipation sedation
Anesthesia time starting from induction of anesthesia till extubation of the patient
Surgical operation time starting from skin incision till skin closure
Emergence time is defined as from discontinuation of inhalational anesthesia till the extubation of the patient
Recovery time is defined as the time from extubation to the time of achieving Aldrete scores 9
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None