Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03572517
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2018-02-07
Brief Title:
Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Comparison of Two Different Anesthetic Techniques on Incidence of Postoperative Delirium in Cancer Patients After Laparoscopic Surgery in Trendelenburg Position A Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Postoperative delirium is an acute mental syndrome that is caused by diffuse cerebral dysfunction resulting from the action of predisposing and precipitating factors acting together It is associated with an increase in mortality and postoperative morbidity and prolongs the period of hospitalization of the patient Videolaparoscopic surgery has been increasingly used as a therapeutic and diagnostic method In order to have a good visualization of the anatomical structures on which it will act it is necessary to introduce gas into the cavity a mandatory component known as pneumoperitoneum This technique gives special characteristics for the conduction of anesthesia since the positive intra-abdominal pressure results in changes in the patients physiology Some types of laparoscopic surgery require the position of Trendelenburg for better visualization of the operative field Among the changes related to this position are the increase in cardiac output and intracranial pressure
In order to optimize the anesthetic procedure anesthetic blocks have been increasingly used especially the spinal The association of general anesthesia with spinal anesthesia followed by its contraindications is advantageous because lower doses of anesthetic agents are necessary for the maintenance of general anesthesia This association results in an earlier awakening a reduction of nausea vomiting postoperative pain length of hospital stay cost effectiveness and greater patient satisfaction As a disadvantage by associating general anesthesia with spinal anesthesia patients become susceptible to the adverse events of spinal anesthesia Among these the most common are headache hypotension nausea and vomiting pruritus urinary retention and tremor Performing spinal anesthesia with opioids alone without the use of local anesthetic is also possible with morphine being the most used The benefit of this variation of technique is analgesia for a period of 12 to 24 hours without the cardiovascular consequences resulting from the action of the local anesthetic
JUSTIFICATION There are no studies in the literature evaluating The objective of this study is to analyze if the anesthetic techniques employed general anesthesia or general anesthesia associated with subarachnoid block for videolaparoscopic oncologic surgeries in Trendelenburg position differ in relation to the incidence of delirium in the postoperative period
In order to optimize the anesthetic procedure anesthetic blocks have been increasingly used especially the spinal The association of general anesthesia with spinal anesthesia followed by its contraindications is advantageous because lower doses of anesthetic agents are necessary for the maintenance of general anesthesia This association results in an earlier awakening a reduction of nausea vomiting postoperative pain length of hospital stay cost effectiveness and greater patient satisfaction As a disadvantage by associating general anesthesia with spinal anesthesia patients become susceptible to the adverse events of spinal anesthesia Among these the most common are headache hypotension nausea and vomiting pruritus urinary retention and tremor Performing spinal anesthesia with opioids alone without the use of local anesthetic is also possible with morphine being the most used The benefit of this variation of technique is analgesia for a period of 12 to 24 hours without the cardiovascular consequences resulting from the action of the local anesthetic
JUSTIFICATION There are no studies in the literature evaluating The objective of this study is to analyze if the anesthetic techniques employed general anesthesia or general anesthesia associated with subarachnoid block for videolaparoscopic oncologic surgeries in Trendelenburg position differ in relation to the incidence of delirium in the postoperative period
Detailed Description:
Patients will be allocated sequentially in 2 groups Sequential allocation will be used in order to control age as a possible confounding factor for the outcome of interest
These patients will be monitored intraoperatively with electrocardiogram ECG noninvasive pressure pulse oximetry capnography BIS monitor of neuromuscular blocker TOF esophageal temperature and Trendelenburg angle
The measured moments will be patient entry in the operating room after pre-anesthetic medication anesthetic pre-induction after anesthetic induction after surgical incision after pneumoperitoneum infusion after Trendelenburg position every 15 minutes until the end of the procedure and after extubation
All patients will receive morphine 50 mcg via the spinal route All patients will receive intravenous pre-anesthetic medication midazolam 003 mg kg for comfort during spinal anesthesia and 500 ml of crystalloid solution prior to blockade associated with 4 ml kg hour of crystalloid solution plus volume to be depended of clinical parameters
Subarachnoid block will be performed in the seated position antisepsis asepsis with alcoholic chlorhexidine location of the L3 L4 space needle puncture with whitacre 27 G barbotation of 05 ml and injection lasting 5 to 7 seconds
Spinal morphine will be performed with the same anesthetic technique described in the subarachnoid block
A general anesthetic with pre-oxygenation 8 liters minute for 5 minutes fentanyl 3 mcg kg propofol 2 mg kg rocuronium 06 mg kg will be performed Patients will be ventilated with a mixture of oxygen and air through an inspired fraction of 40 oxygen and maintaining an expired concentration of carbon dioxide between 35 and 45 mmHg Anesthesia will be maintained with remifentanil ng ml through Mintos pharmacokinetic model BBraun infusion syringe - Perfusor Space model and desflurane Fe
Hypnosis will be guided by maintaining BIS between 40 and 60 and the dose of remifentanil will be adjusted by vital signs
Patients with medium arterial pressure with values lower than 60 mmHg will be medicated with vasopressors depending on heart rate If heart rate is greater than 60 beats per minute bpm metaraminol 05 mg will be used and 5 mg ephedrine will be used if heart rate less than 60 bpm
In both groups the patients will be kept warm with a thermal blanket and will have their esophageal temperature measured 40 cm from the incisor teeth
After the surgical procedure neuromuscular blockade will be antagonized with suggamadex according to the monitoring of neuromuscular blockade through TOF
Deep block at least 1 to 2 responses in PTC but prior to the appearance of T2 ie the second response to TOF 4 mg kg
Moderate block after onset of T2 2mg kg
16 mg kg is recommended if there is a clinical condition requiring rapid reversal approximately 3 minutes following the single dose of rocuronium at 12 mg kg
After 5 minutes of extubation vital signs blood pressure heart rate saturation will be collected and the patient will be evaluated for the presence of delirium Dipyrone 2 grams and parecoxib 40 mg will be performed without contraindication for postoperative analgesia
Patients will then be referred to the anesthetic recovery room where they will continue to be monitored with ECG noninvasive pressure and pulse oximeters They will also be evaluated for pain in the numerical estimate scale NRS 0 no pain up to 10 maximum pain on arrival and every 30 minutes until the time of discharge into the room Those who present pain with NRS greater than 4 in PACU will be treated with morphine 1 mg every 10 minutes Those with nausea vomiting will be given alizapride 50 mg
Patients will be assessed with regard to the appearance of delirium by means of CAM Confusion Assemption Method in association with the Richmond Agitation Sedation Scale RASS scale
CAM is a simple screening method based on the following four questions with Criteria 1 and 2 plus 3 or 4 being present
1 Acute onset Is there evidence of acute change in the patients underlying mental state
2 Attention Disorder Has the patient had difficulty focusing on his or her attention for example was easily distracted or had difficulty following what was being said
3 Disorganized thinking Was the patients thinking disorganized or incoherent with dispersive or irrelevant conversion unclear or illogical flow of ideas or unpredictable change of subject
4 Changes in level of consciousness Does the patient present altered level of consciousness such as lethargy torporous comatose The RASS was developed with the purpose of characterizing the level of consciousness and agitation Signs of hyperactive delirium are defined as scores ranging from 1 anxious patient 2 frequent uncoordinated unintentional movements fight against ventilation 3 aggressive to 4 very aggressive Signs of hypoactive delirium are defined as RASS ranging from - 5 patient does not respond - 4 no response to voice sound -3 movements or ocular opening to voice sound -2 awakens briefly - 1 not completely alert to 0 patient calm or sleepy
This evaluation will be performed by nurses previously trained on arrival at PACU every 30 minutes until discharge from the post-anesthetic recovery room and 24 hours after the patients discharge from the hospital In cases where the patient has an episode of persistent delirium for more than 1 hour the evaluation of a psychiatrist will be requested for follow-up and treatment
These patients will be monitored intraoperatively with electrocardiogram ECG noninvasive pressure pulse oximetry capnography BIS monitor of neuromuscular blocker TOF esophageal temperature and Trendelenburg angle
The measured moments will be patient entry in the operating room after pre-anesthetic medication anesthetic pre-induction after anesthetic induction after surgical incision after pneumoperitoneum infusion after Trendelenburg position every 15 minutes until the end of the procedure and after extubation
All patients will receive morphine 50 mcg via the spinal route All patients will receive intravenous pre-anesthetic medication midazolam 003 mg kg for comfort during spinal anesthesia and 500 ml of crystalloid solution prior to blockade associated with 4 ml kg hour of crystalloid solution plus volume to be depended of clinical parameters
Subarachnoid block will be performed in the seated position antisepsis asepsis with alcoholic chlorhexidine location of the L3 L4 space needle puncture with whitacre 27 G barbotation of 05 ml and injection lasting 5 to 7 seconds
Spinal morphine will be performed with the same anesthetic technique described in the subarachnoid block
A general anesthetic with pre-oxygenation 8 liters minute for 5 minutes fentanyl 3 mcg kg propofol 2 mg kg rocuronium 06 mg kg will be performed Patients will be ventilated with a mixture of oxygen and air through an inspired fraction of 40 oxygen and maintaining an expired concentration of carbon dioxide between 35 and 45 mmHg Anesthesia will be maintained with remifentanil ng ml through Mintos pharmacokinetic model BBraun infusion syringe - Perfusor Space model and desflurane Fe
Hypnosis will be guided by maintaining BIS between 40 and 60 and the dose of remifentanil will be adjusted by vital signs
Patients with medium arterial pressure with values lower than 60 mmHg will be medicated with vasopressors depending on heart rate If heart rate is greater than 60 beats per minute bpm metaraminol 05 mg will be used and 5 mg ephedrine will be used if heart rate less than 60 bpm
In both groups the patients will be kept warm with a thermal blanket and will have their esophageal temperature measured 40 cm from the incisor teeth
After the surgical procedure neuromuscular blockade will be antagonized with suggamadex according to the monitoring of neuromuscular blockade through TOF
Deep block at least 1 to 2 responses in PTC but prior to the appearance of T2 ie the second response to TOF 4 mg kg
Moderate block after onset of T2 2mg kg
16 mg kg is recommended if there is a clinical condition requiring rapid reversal approximately 3 minutes following the single dose of rocuronium at 12 mg kg
After 5 minutes of extubation vital signs blood pressure heart rate saturation will be collected and the patient will be evaluated for the presence of delirium Dipyrone 2 grams and parecoxib 40 mg will be performed without contraindication for postoperative analgesia
Patients will then be referred to the anesthetic recovery room where they will continue to be monitored with ECG noninvasive pressure and pulse oximeters They will also be evaluated for pain in the numerical estimate scale NRS 0 no pain up to 10 maximum pain on arrival and every 30 minutes until the time of discharge into the room Those who present pain with NRS greater than 4 in PACU will be treated with morphine 1 mg every 10 minutes Those with nausea vomiting will be given alizapride 50 mg
Patients will be assessed with regard to the appearance of delirium by means of CAM Confusion Assemption Method in association with the Richmond Agitation Sedation Scale RASS scale
CAM is a simple screening method based on the following four questions with Criteria 1 and 2 plus 3 or 4 being present
1 Acute onset Is there evidence of acute change in the patients underlying mental state
2 Attention Disorder Has the patient had difficulty focusing on his or her attention for example was easily distracted or had difficulty following what was being said
3 Disorganized thinking Was the patients thinking disorganized or incoherent with dispersive or irrelevant conversion unclear or illogical flow of ideas or unpredictable change of subject
4 Changes in level of consciousness Does the patient present altered level of consciousness such as lethargy torporous comatose The RASS was developed with the purpose of characterizing the level of consciousness and agitation Signs of hyperactive delirium are defined as scores ranging from 1 anxious patient 2 frequent uncoordinated unintentional movements fight against ventilation 3 aggressive to 4 very aggressive Signs of hypoactive delirium are defined as RASS ranging from - 5 patient does not respond - 4 no response to voice sound -3 movements or ocular opening to voice sound -2 awakens briefly - 1 not completely alert to 0 patient calm or sleepy
This evaluation will be performed by nurses previously trained on arrival at PACU every 30 minutes until discharge from the post-anesthetic recovery room and 24 hours after the patients discharge from the hospital In cases where the patient has an episode of persistent delirium for more than 1 hour the evaluation of a psychiatrist will be requested for follow-up and treatment
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