Dexmedetomidine Versus Ketamine as Adjuvants in Bariatric Surgery
NCT ID: NCT06738043
Last Updated: 2024-12-17
Study Results
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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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-12-20
2025-12-20
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexmedetomidine Group
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.
Dexmedetomidine infusion
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 Group
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.
Ketamine infusion
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.
Control Group
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.
Normal Saline Infusion (Placebo)
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.
Interventions
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Dexmedetomidine infusion
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
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ahmed Abdalla Shalaby
Anesthesiology, Intensive Care and Pain Management Resident
Central Contacts
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Other Identifiers
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11/2024ANET15
Identifier Type: -
Identifier Source: org_study_id