Comparison of Dexmedetomidine + Ketamine for Postoperative Pain in C-Section
NCT ID: NCT07022821
Last Updated: 2025-06-18
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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RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2025-05-16
2025-08-31
Brief Summary
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Detailed Description
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Various analgesic therapy techniques include oral or parenteral opioids, nonsteroidal anti-inflammatory medications, and neuraxial blocks with or without adjuvants, with unclear efficacy and/or substantial adverse effects. While opioids are the gold standard for postoperative pain management, they are associated with respiratory depression, nausea, vomiting, and other adverse effects that increase patient suffering. In recent years, there has been a shift toward minimizing opioid use and developing guidelines for enhanced postpartum recovery. Studies have explored combining opioids with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), ketamine, clonidine, and dexmedetomidine for effective pain relief while avoiding opioid-related side effects.
Dexmedetomidine, a highly selective α2-agonist, is beneficial in reducing tension and anxiety. It may be effective in the management of postoperative pain due to its analgesic properties. Dexmedetomidine acts at spinal and supraspinal sites, producing antinociceptive effects via stimulation of α2-receptors in the locus coeruleus.
Ketamine has been shown to be an effective painkiller with few side effects when used in small doses. Its analgesic effects result from N-methyl-D-aspartate (NMDA) receptor antagonism, and it also interacts with opioid receptors in the brain and spinal cord. When combined with benzodiazepines, ketamine's adverse effects are further minimized.
The combination of ketamine and dexmedetomidine offers several benefits, including hemodynamic stability, absence of respiratory depression, improved postoperative analgesia, and smoother recovery. Previous work has demonstrated a synergistic effect when these agents are used together, providing excellent symptom relief while minimizing side effects.
This study seeks to address the current gap in literature regarding the comparative efficacy of different doses of dexmedetomidine combined with a fixed dose of ketamine for post-cesarean analgesia. It aims to evaluate three infusion doses of dexmedetomidine combined with ketamine using postoperative pain scores as the primary outcome measure. The findings may help optimize pain management protocols following cesarean section
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low-Dose Dexmedetomidine
Dexmedetomidine 0.2 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion
Dexmedetomidine
Dexmedetomidine infusion at one of the following doses:
Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
ketamine
Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups.
Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
Medium-Dose Dexmedetomidine
Dexmedetomidine 0.3 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion
Dexmedetomidine
Dexmedetomidine infusion at one of the following doses:
Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
ketamine
Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups.
Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
High-Dose Dexmedetomidine
Dexmedetomidine 0.4 µg/kg/hr + Ketamine 0.25 mg/kg/hr infusion
Dexmedetomidine
Dexmedetomidine infusion at one of the following doses:
Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
ketamine
Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups.
Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
Interventions
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Dexmedetomidine
Dexmedetomidine infusion at one of the following doses:
Group A: 0.2 µg/kg/hr Group B: 0.3 µg/kg/hr Group C: 0.4 µg/kg/hr Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
ketamine
Ketamine infusion at a fixed dose of 0.25 mg/kg/hr administered in all three groups.
Route of Administration: Intravenous Frequency: Continuous infusion during postoperative period
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) Physical Status II
* Provided informed consent
Exclusion Criteria
* Presence of significant comorbidities
* Emergency surgery
* Documented psychiatric illness
18 Years
50 Years
FEMALE
No
Sponsors
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Fatima Memorial Hospital
OTHER
Responsible Party
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Ahmed Naeem
Principal Investigator
Locations
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Department of Anesthesiology, Fatima Memorial Hospital
Lahore, Punjab Province, Pakistan
Countries
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Central Contacts
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Other Identifiers
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FMH-KETODEX-CS-2025
Identifier Type: -
Identifier Source: org_study_id
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