Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery

Tanta University

Status: Not yet enrolling

Conditions: Postoperative Pain; Bariatric Surgery; Obesity

Treatments: Drug: Dexmedetomidine infusion; Drug: Ketamine infusion; Drug: Normal Saline Infusion (Placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT06738043

11/2024ANET15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Dexmedetomidine Group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine infusion

Ketamine Group

Experimental group

Description:

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.

Treatment:

Drug: Ketamine infusion

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline Infusion (Placebo)