Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery

Not Applicable

Not yet recruiting

• Conditions: Obesity; Postoperative Pain; Bariatric Surgery
• Interventions: Drug: Dexmedetomidine infusion; Drug: Ketamine infusion; Drug: Normal Saline Infusion (Placebo)

• Registration Number: NCT06738043
• Lead Sponsor: Tanta University

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.

Detailed Description

This study is a prospective, randomized controlled interventional trial evaluating the analgesic efficacy and opioid-sparing effects of dexmedetomidine and low-dose ketamine as adjuvants in bariatric surgery. Ninety patients meeting the inclusion criteria will be enrolled and randomized into three groups:

* Dexmedetomidine Group: Patients will receive a bolus dose of dexmedetomidine (0.5 µg/kg) followed by a continuous infusion (0.5 µg/kg/h) until 10 minutes before the end of surgery.

* Ketamine Group: Patients will receive a bolus dose of ketamine (0.3 mg/kg) followed by a continuous infusion (0.3 mg/kg/h) until 10 minutes before the end of surgery.

* Control Group: Patients will receive an equal volume of normal saline as a placebo.

Objectives

The primary objective is to compare intra- and postoperative morphine consumption between groups. Secondary objectives include:

* Pain assessment using the Numeric Rating Scale (NRS) at multiple time points postoperatively.

* Time to first request for rescue analgesia.

* Hemodynamic stability (heart rate and mean arterial pressure).

* Patient satisfaction assessed using a 5-point scale.

* Incidence of adverse effects such as nausea, vomiting, bradycardia, and respiratory depression.

Study Protocol All patients will undergo standard preoperative assessments, including history, physical examination, and laboratory investigations. General anesthesia will be induced and maintained per institutional protocols. Postoperatively, pain management will follow a stepwise approach, with intravenous paracetamol as rescue analgesia.

Significance Given the high prevalence of obesity-related comorbidities, bariatric surgery patients are at increased risk for postoperative complications, particularly with opioid use. This study addresses the need for opioid-sparing pain management strategies, potentially reducing the risks of opioid-related adverse effects and improving patient outcomes.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2024-12-20
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Group	Dexmedetomidine infusion	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.
Ketamine Group	Ketamine infusion	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.
Control Group	Normal Saline Infusion (Placebo)	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.

Primary Outcome Measures

Name	Time	Method
Total Morphine Consumption Intra- and Postoperatively	From the start of anesthesia to 24 hours postoperatively	The total dose of morphine (measured in mg) consumed by participants intraoperatively and within the first 24 hours postoperatively. This includes morphine administered as part of the anesthesia protocol and as rescue analgesia post-surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain Scores (Numeric Rating Scale - NRS)	At 1, 2, 4, 8, 12, 16, and 24 hours postoperatively	Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores will be recorded at specific intervals postoperatively (1, 2, 4, 8, 12, 16, and 24 hours).
Time to First Request for Rescue Analgesia	24 hours postoperatively	The duration (in hours) from the end of surgery to the first request for rescue analgesia (intravenous morphine) by the participant.
Hemodynamic Stability (Heart Rate)	From baseline (pre-surgery) to 24 hours postoperatively	Heart rate (HR) will be monitored and recorded at specific intervals during and after surgery to assess hemodynamic stability.
Hemodynamic Stability (Mean Arterial Pressure)	From baseline (pre-surgery) to 24 hours postoperatively	Mean arterial pressure (MAP) will be monitored and recorded at specific intervals during and after surgery to assess hemodynamic stability.
Total Analgesic Consumption (Other Than Morphine)	At 24 hours postoperatively	The total dose of non-morphine analgesics (e.g., paracetamol) administered postoperatively to manage pain within the first 24 hours after surgery.
Patient Satisfaction with Pain Management	At 24 hours postoperatively	Patient satisfaction will be assessed using a 5-point Likert scale (1 = highly satisfied, 2 = satisfied, 3 = neutral, 4 = unsatisfied, 5 = highly unsatisfied) based on their postoperative pain management experience.