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Ketamine for Pain Relief in Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03052673
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Nitin Sethi, Sir Ganga Ram Hospital

Brief Summary:

The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve gastrectomy are collectively covered under the term `bariatric surgery`. The growth of bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure patient safety and facilitate post-surgery outcome. Conventionally, balanced general anaesthesia techniques routinely use opioids peri-operatively for intra-operative haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the same technique when employed in the morbidly obese patients hampers early and intermediate postoperative recovery due to the occurrence of side effects, such as, sedation, PONV, respiratory depression, depressed GI-mobility. The above stated side effects, have lead to increased propensity for postoperative cardiac and pulmonary complications. Obese patients are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be employed judiciously in these patients. On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimise opioid use and employ some other drugs which besides having analgesia, has a opioid-sparing effect also.

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key advantage of ketamine is that it can reduces post-operative pain and use of opioid when used per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to decrease opioid-related postoperative morbidity in these patients undergoing bariatric surgery.In view of the above, a clinical research is highly desirable to study techniques to decrease the use of opioids in obese surgical patients.This prospective randomised two-arm study aims to assess the effect of low-dose ketamine on postoperative pain relief and opioid-sparing ability in obese patients undergoing bariatric surgery.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Fentanyl Drug: ketamine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

76 patients belonging to ASA physical patients status II and III of either sex, scheduled to undergo laparoscopic bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass) under general anaesthesia. The patients will be randomly allocated by computer generated numbers to one of the following two groups of 38 patients each.

Group 1[Ketamine + Fentanyl Group, n=38]: Pre-induction fentanyl 1-mcg/kg, ketamine 0.5-mg/kg after induction, followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr + ketamine infusion of 0.2-mg/kg/hr.

Group 2[Fentanyl Group, n=38]:Pre-induction fentanyl 1-mcg/kg, saline after induction followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr + saline infusion.

Both the groups will receive intravenous PCA of fentanyl post-operatively

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The patient and the attending anaesthesiologist will be blinded to the intraoperative infusions used. Postoperative patient recovery profile will also be evaluated by an independent assess or blinded to the intraoperative anaesthesia technique.
Primary Purpose: Treatment
Official Title: Per-operative Low-Dose Ketamine For Postoperative Pain Relief In Patients Undergoing Bariatric Surgery: A Randomised Study
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketamine + Fentanyl Group

Patients will receive pre-induction fentanyl 1-mcg/kg, ketamine 0.5-mg/kg after induction, followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr + ketamine infusion of 0.2-mg/kg/hr.

Postoperative analgesia will be provided with Intravenous Patient Controlled Analgesia (IV-PCA) pump containing fentanyl citrate-2.5 mcg/ml, which will be attached to all the patients upon shifting to the recovery room. The IV-PCA pump settings will be as follows: 0-ml basal dose; 4-ml PCA dose; 15-minutes lock out interval.

Drug: Fentanyl
Fentanyl 1mcg/kg will be given at induction of anaesthesia followed by intraoperative infusion of 0.5 mcg/kg/hr in both the arms . Postoperatively IV-PCA pump containing fentanyl will be attached to patients in both the arms

Drug: ketamine
Ketamine 0.5 mg/kg will be given post-induction of anaesthesia followed by infusion of 0.5 mcg/kg /hr in the Ketamine + Fentanyl group arm

Active Comparator: Fentanyl Group

Patients will receive pre-induction fentanyl 1-mcg/kg,followed by intraoperative fentanyl infusion of 0.5-mcg/kg/hr.

Postoperative analgesia will be provided with Intravenous Patient Controlled Analgesia (IV-PCA) pump containing fentanyl citrate-2.5 mcg/ml, which will be attached to all the patients upon shifting to the recovery room. The IV-PCA pump settings will be as follows: 0-ml basal dose; 4-ml PCA dose; 15-minutes lock out interval.

Drug: Fentanyl
Fentanyl 1mcg/kg will be given at induction of anaesthesia followed by intraoperative infusion of 0.5 mcg/kg/hr in both the arms . Postoperatively IV-PCA pump containing fentanyl will be attached to patients in both the arms




Primary Outcome Measures :
  1. Efficacy of Postoperative Analgesia [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    will be assessed using visual analogue scale (VAS) score

  2. Postoperative Fentanyl Consumption in micrograms [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    Amount of fentanyl consumed using the IV-PCA pump will be calculated


Secondary Outcome Measures :
  1. Time to eye opening in minutes [ Time Frame: From end of anaesthesia till 20-minutes postoperatively ]
    Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

  2. Time to extubation in minutes [ Time Frame: From end of anaesthesia till 30-minutes postoperatively ]
    Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

  3. Changes in intraoperative heart rate (beats per minute) [ Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    Comparison of intraoperative heart rate between both the arms will be done

  4. Changes in intraoperative blood pressure- systolic, diastolic, and mean (mmHg) [ Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    Comparison of intraoperative blood pressure- systolic, diastolic, and mean between both the arms will be done

  5. Postoperative Sedation [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    will be assessed using Modified Observer's assessment of alertness/sedation scale (OASS)

  6. Postoperative Nausea and Vomiting [ Time Frame: From end of anaesthesia till 24-hours postoperatively ]
    will be assessed using PONV Scale



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of age 18-60 years
  • BMI > 35 kg/m2
  • Either sex
  • ASA physical status II & III
  • undergoing laparoscopic bariatric surgery

Exclusion Criteria:

  • Patients refusal
  • ASA physical status: IV
  • History of hypersensitivity to fentanyl and/or ketamine
  • Chronic opioid use
  • History of substance abuse
  • Metabolic disorders
  • Seizure disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052673


Locations
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India
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Sir Ganga Ram Hospital
Investigators
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Principal Investigator: Haider Hussain, MBBS Sir Ganga Ram Hospital, New Delhi, INDIA
Study Chair: Anil K Jain, MD Sir Ganga Ram Hospital, New Delhi, INDIA
Study Director: Amitabh Dutta, MD Sir Ganga Ram Hospital, New Delhi, INDIA
Principal Investigator: Nitin Sethi, DNB Sir Ganga Ram Hospital, New Delhi, INDIA
Principal Investigator: Praveen Bhatia, MS Sir Ganga Ram Hospital, New Delhi, INDIA

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Responsible Party: Dr Nitin Sethi, Doctor & Associate Professor, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT03052673     History of Changes
Other Study ID Numbers: EC/01/17/1120
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr Nitin Sethi, Sir Ganga Ram Hospital:
ketamine
fentanyl
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia