Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery

NCT06738043 | Not Yet Recruiting

• 1 other identifier: 11/2024ANET15
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to compare the analgesic efficacy of dexmedetomidine infusion versus low-dose ketamine infusion as adjuvants in bariatric surgery. The study includes 90 patients undergoing bariatric surgery at Menoufia University Hospital, randomized into three groups: dexmedetomidine, ketamine, and control (placebo). Primary outcomes include total morphine consumption intra- and post-operatively. Secondary outcomes include postoperative pain scores, total analgesic consumption, time to first analgesic request, hemodynamic parameters, and patient satisfaction. This study seeks to explore safer, more effective pain management strategies to minimize opioid use in bariatric surgery patients.

Conditions

Obesity; Postoperative Pain; Bariatric Surgery

Keywords

Dexmedetomidine; Ketamine; Opioid-Sparing Analgesia; Randomized Controlled Trial; Pain Management

Outcome Measures

Primary Outcomes (1)

• Postoperative Total Morphine Consumption

  The total dose of morphine, measured in mg, administered to each participant during the first 24 hours postoperatively for pain control.

  Within the first 24 hours postoperatively

Secondary Outcomes (7)

• Postoperative Pain Scores (Numeric Rating Scale - NRS)

  At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

• Time to First Request for Rescue Analgesia

  24 hours postoperatively

• Hemodynamic Stability (Heart Rate)

  From baseline (pre-surgery) to 24 hours postoperatively

• Hemodynamic Stability (Mean Arterial Pressure)

  From baseline (pre-surgery) to 24 hours postoperatively

• Total Analgesic Consumption (Other Than Morphine)

  At 24 hours postoperatively

Study Arms (3)

Dexmedetomidine Group

EXPERIMENTAL

Participants in this group will receive a bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of dexmedetomidine at 0.5 µg/kg/h until 10 minutes before the end of surgery.

Drug: Dexmedetomidine infusion

Ketamine Group

EXPERIMENTAL

Participants in this group will receive a bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of ketamine at 0.3 mg/kg/h until 10 minutes before the end of surgery.

Drug: Ketamine infusion

Control Group

PLACEBO COMPARATOR

Participants in this group will receive a bolus dose of 0.9% normal saline over 10 minutes before induction of anesthesia. This will be followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery.

Drug: Normal Saline Infusion (Placebo)

Interventions

Dexmedetomidine infusion DRUG

A bolus dose of dexmedetomidine (0.5 µg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.5 µg/kg/h until 10 minutes before the end of surgery.

Dexmedetomidine Group

Ketamine infusion DRUG

A bolus dose of ketamine (0.3 mg/kg ideal body weight) diluted in 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion at 0.3 mg/kg/h until 10 minutes before the end of surgery.

Ketamine Group

Normal Saline Infusion (Placebo) DRUG

A bolus dose of 0.9% normal saline is infused over 10 minutes before induction of anesthesia, followed by a continuous infusion of 0.9% normal saline until 10 minutes before the end of surgery.

Control Group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-60 years.
• Both sexes.
• Body mass index (BMI) \> 35 kg/m², scheduled for bariatric surgery.
• American Society of Anesthesiologists (ASA) physical status I-II.

You may not qualify if:

• History of hypersensitivity to dexmedetomidine or ketamine.
• History of substance abuse or chronic opioid use.
• American Society of Anesthesiologists (ASA) physical status III or IV.
• Severe hepatic or renal impairment.
• Cardiopulmonary disorders.
• Severe diabetes mellitus.
• Psychiatric disorders, seizures, uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), or heart block.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Obesity; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Ahmed A Shalaby, M.B.B.Ch

CONTACT

01020479848; phdoc97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation will be concealed using sequentially numbered, sealed envelopes. A nurse not involved in patient care will open the envelope after induction of anesthesia to assign patients to groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology, Intensive Care and Pain Management Resident

Model Details: Patients will be randomized into three parallel groups: dexmedetomidine, ketamine, or control (placebo) groups, each receiving specific interventions based on the protocol.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting information will be available starting 6 months after publication of the study results and will remain accessible for 5 years.
• Access Criteria: Access to IPD and supporting information will be provided to qualified researchers upon reasonable request. Requests should include a proposal outlining the intended research objectives, ethical approval, and a data-sharing agreement. Access will be granted via secure data transfer or repository.