Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343753
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-19
Brief Title:
Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Quality of Recovery After Laparoscopic Cholecystectomy A Prospective Randomised Controlled Trial Comparing Opioid Free Multimodal Analgesia Versus Opioid Based Anesthesia
Status:
RECRUITING
Status Verified Date:
2024-06
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 aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale QoR-15 for participants receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy
Detailed Description:
Type of Study interventional randomized and double-blinded controlled trial Study Setting The operating theatres of Ain Shams University Hospitals Study Period over one year
Study Procedures
Patients will be randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the two groups according to the used analgesia into
o Group Traditional balanced anesthesia TBA Analgesia will be provided by fentanyl in induction and maintenance according to Ideal Body Weight IBW
o Group Opioid free anesthesia OFA Analgesia will be provided by syringe containing ketamine Lidocaine and Dexmedetomidine in induction and maintenance according to lean body weight LBW
Both groups will receive port site infiltration with bupivacaine 025 20 ml
Pre-operatively all patients will receive Ondansetron 4 mg IV and metoclopramide 10 mg intravenously IV
After proper assessment of the airway and anticipation of difficult airway all patients will receive midazolam 2 mg IV for sedation and we will start pre-oxygenation with 100 O2 on 8 Lmin for 3 min via face mask
All patients will receive general anesthesia induction by propofol 15-2 mgkg LBW analgesia according to patient group and muscle relaxation by atracurium 05 mgKg LBW to facilitate endotracheal intubation Anesthesia will be maintained by isoflurane whose concentration will be adjusted according to patients hemodynamics Analgesia used in the study will be prepared in the pharmacy and will be given a code so that the anesthetist in charge will be blinded to the randomisation group and the analgesia used The analgesia will be prepared as follows
Fentanyl 2 mgkg LBW as induction dose in 10 ml syringe to be given over 10 minutes and 1 mgkgh in 50 ml syringe as infusion during operation starting before skin incision for Group TBA
Group OFA
Induction
Ketamine 05 mgkg IBW Lidocaine 1 mgkg and dexmedetomidine 05 mgkg LBW for induction to be given in 10 ml syringe over 10 minutes
Maintenance The maintenance mixture - 50 cc syringe containing
50 mcg Dexmedetomidine 05 cc of standard 100 mcgml solution 50 mg Ketamine 500 mg Lidocaine 25 ml of standard 2 solution NaCl up to total 50 ml Ketamine 01 mgkgh IBW Lidocaine 1 mgkgh and dexmedetomidine 01 mgkgh LBW as infusion during operation starting before skin incision 1ml10 kg of solution from The maintenance mixture syringe After skin preparation and before port insertion 20 ml of 025 bupivacaine solution was infiltrated through the abdominal wall 4ml around each port site in both groups
About 15 min before the end of the operation reduce maintenance dose to 05 ml10 kgh Ventilator Settings the ventilation will be achieved with a volume-controlled mode ventilation respiratory rate adjusted according to EtCO2 to range between 35-45 mmHg a tidal volume of 6-8 mlkg and mixture of gases in proportion 50 oxygen and 50 air with PEEP 5 cm H2O using a closed circle system and with a total fresh gas flow rate of 3Lmin
Analgesic infusion will be stopped after skin closure Paracetamol 1 gm and diclofenac 75 mg incorporated in IV infusion fluids will be given intra-operatively before emergence
At the end of surgery muscle relaxation will be reversed with neostigmine up to 5 mg and atropine up to 2 mg
These procedures will be done by supervisors and experts Patients will be kept after extubation for observation in PACU until fulfilling an Aldrete score of 9
Patients will receive metoclopramide 10 mg intravenously IV and Ondansetron 4 mg IV as post-operative nausea and vomiting PONV treatment
Post-operative analgesia will be offered in regular doses of paracetamol 1 gm IV every 6 hours for the following 24 hours and rescue doses of IV nalbuphine 5 mg Up to 20 mg maxdose If VAS score is 3
The anesthetist evaluating outcomes in PACU and in the ward will not participate in the anesthesia and will not be aware of the randomisation group
Study Procedures
Patients will be randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the two groups according to the used analgesia into
o Group Traditional balanced anesthesia TBA Analgesia will be provided by fentanyl in induction and maintenance according to Ideal Body Weight IBW
o Group Opioid free anesthesia OFA Analgesia will be provided by syringe containing ketamine Lidocaine and Dexmedetomidine in induction and maintenance according to lean body weight LBW
Both groups will receive port site infiltration with bupivacaine 025 20 ml
Pre-operatively all patients will receive Ondansetron 4 mg IV and metoclopramide 10 mg intravenously IV
After proper assessment of the airway and anticipation of difficult airway all patients will receive midazolam 2 mg IV for sedation and we will start pre-oxygenation with 100 O2 on 8 Lmin for 3 min via face mask
All patients will receive general anesthesia induction by propofol 15-2 mgkg LBW analgesia according to patient group and muscle relaxation by atracurium 05 mgKg LBW to facilitate endotracheal intubation Anesthesia will be maintained by isoflurane whose concentration will be adjusted according to patients hemodynamics Analgesia used in the study will be prepared in the pharmacy and will be given a code so that the anesthetist in charge will be blinded to the randomisation group and the analgesia used The analgesia will be prepared as follows
Fentanyl 2 mgkg LBW as induction dose in 10 ml syringe to be given over 10 minutes and 1 mgkgh in 50 ml syringe as infusion during operation starting before skin incision for Group TBA
Group OFA
Induction
Ketamine 05 mgkg IBW Lidocaine 1 mgkg and dexmedetomidine 05 mgkg LBW for induction to be given in 10 ml syringe over 10 minutes
Maintenance The maintenance mixture - 50 cc syringe containing
50 mcg Dexmedetomidine 05 cc of standard 100 mcgml solution 50 mg Ketamine 500 mg Lidocaine 25 ml of standard 2 solution NaCl up to total 50 ml Ketamine 01 mgkgh IBW Lidocaine 1 mgkgh and dexmedetomidine 01 mgkgh LBW as infusion during operation starting before skin incision 1ml10 kg of solution from The maintenance mixture syringe After skin preparation and before port insertion 20 ml of 025 bupivacaine solution was infiltrated through the abdominal wall 4ml around each port site in both groups
About 15 min before the end of the operation reduce maintenance dose to 05 ml10 kgh Ventilator Settings the ventilation will be achieved with a volume-controlled mode ventilation respiratory rate adjusted according to EtCO2 to range between 35-45 mmHg a tidal volume of 6-8 mlkg and mixture of gases in proportion 50 oxygen and 50 air with PEEP 5 cm H2O using a closed circle system and with a total fresh gas flow rate of 3Lmin
Analgesic infusion will be stopped after skin closure Paracetamol 1 gm and diclofenac 75 mg incorporated in IV infusion fluids will be given intra-operatively before emergence
At the end of surgery muscle relaxation will be reversed with neostigmine up to 5 mg and atropine up to 2 mg
These procedures will be done by supervisors and experts Patients will be kept after extubation for observation in PACU until fulfilling an Aldrete score of 9
Patients will receive metoclopramide 10 mg intravenously IV and Ondansetron 4 mg IV as post-operative nausea and vomiting PONV treatment
Post-operative analgesia will be offered in regular doses of paracetamol 1 gm IV every 6 hours for the following 24 hours and rescue doses of IV nalbuphine 5 mg Up to 20 mg maxdose If VAS score is 3
The anesthetist evaluating outcomes in PACU and in the ward will not participate in the anesthesia and will not be aware of the randomisation group
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