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NCT Number: NCT06738043

Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Postoperative Total Morphine Consumption

    Time frame: Within the first 24 hours postoperatively

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

Secondary outcomes

  1. Postoperative Pain Scores (Numeric Rating Scale - NRS)

    Time frame: 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).

  2. Time to First Request for Rescue Analgesia

    Time frame: 24 hours postoperatively

    The duration (in hours) from the end of surgery to the first request for rescue analgesia (intravenous morphine) by the participant.

  3. Hemodynamic Stability (Heart Rate)

    Time frame: 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.

  4. Hemodynamic Stability (Mean Arterial Pressure)

    Time frame: 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.

  5. Total Analgesic Consumption (Other Than Morphine)

    Time frame: 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.

  6. Patient Satisfaction with Pain Management

    Time frame: 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.

  7. Intraoperative Fentanyl Consumption

    Time frame: Intraoperatively (From induction of anesthesia until the end of surgery)

    The total dose of fentanyl, measured in µg, administered intraoperatively during anesthesia maintenance.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Shalaby, M.B.B.Ch

CONTACT

[email protected]

01020479848 ext. +2

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Dexmedetomidine Infusion Versus Low Dose Ketamine Infusion as an Adjuvant in Bariatric Surgery: A Randomized Controlled Comparative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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