Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2022-07-01

Brief Summary

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The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods

The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . 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 minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also.

Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance.

Dexmedetomidine is selective α2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .

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Detailed Description

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Conditions

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Morbid Obesity Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Blinding of patients and assigning them randomly to their groups will be done by giving patients serial numbers, using a computer program (Microsoft Excel 365). Investigators will be blinded to group assignments and drug coding.

Study Groups

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Ketamine

This group will receive a bolus dose of Ketamine \[Ketamine HCL - Sterop, Belgium\] (0.3 mg/kg) by the ideal body weight diluted with 0.9% Normal Saline over 10 minutes by 20 ml syringe infused before induction. After which Ketamine infusion (500 mg vial diluted over 50 cc infusion syringe, concentration 10 mg/ml) will start with rate of 0.3 mg/kg/hr till 10 Minutes before the end of the surgery

Group Type EXPERIMENTAL