Ketamine for Pain Relief in Bariatric Surgery

NCT03052673 | Completed Phase 4 DMC

• 1 other identifier: EC/01/17/1120
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

ketamine; fentanyl; postoperative pain

Outcome Measures

Primary Outcomes (2)

• Efficacy of Postoperative Analgesia

  will be assessed using visual analogue scale (VAS) score

  From end of anaesthesia till 24-hours postoperatively

• Postoperative Fentanyl Consumption in micrograms

  Amount of fentanyl consumed using the IV-PCA pump will be calculated

  From end of anaesthesia till 24-hours postoperatively

Secondary Outcomes (6)

• Time to eye opening in minutes

  From end of anaesthesia till 20-minutes postoperatively

• Time to extubation in minutes

  From end of anaesthesia till 30-minutes postoperatively

• Changes in intraoperative heart rate (beats per minute)

  From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively

• Changes in intraoperative blood pressure- systolic, diastolic, and mean (mmHg)

  From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively

• Postoperative Sedation

  From end of anaesthesia till 24-hours postoperatively

Study Arms (2)

Ketamine + Fentanyl Group

ACTIVE COMPARATOR

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; Drug: ketamine

Fentanyl Group

ACTIVE COMPARATOR

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

Interventions

Fentanyl DRUG

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

Fentanyl Group; Ketamine + Fentanyl Group

ketamine DRUG

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

Ketamine + Fentanyl Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Haider Hussain, MBBS

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Anil K Jain, MD

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

• Amitabh Dutta, MD

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY DIRECTOR

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Praveen Bhatia, MS

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor & Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 14, 2017
• Study Start: February 20, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)