Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia (Sedation)
Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia: A Prospective Randomized Double-Blind Trial
This is a prospective, randomized, double-blind clinical study designed to compare the maternal and early neonatal effects of a loading dose of dexmedetomidine versus low-dose ketamine in parturients undergoing elective cesarean delivery under spinal anesthesia.
Participants will be randomly assigned to receive either an intravenous loading dose of dexmedetomidine (1 μg/kg) or intravenous ketamine (0.15 mg/kg) immediately after the establishment of spinal anesthesia. In both groups, sedation will be maintained with a continuous dexmedetomidine infusion at a rate of 0.5 μg/kg/h.
The primary and secondary outcomes include maternal hemodynamic parameters, sedation levels, patient and surgeon satisfaction scores, neonatal Apgar scores, and perioperative adverse events.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, randomized, double-blind clinical study is designed to evaluate and compare the maternal and early neonatal effects of a loading dose of dexmedetomidine versus low-dose ketamine in parturients undergoing elective cesarean delivery under spinal anesthesia.
After providing written informed consent, eligible parturients will be randomly assigned to one of two study groups. Randomization will be performed using a computer-generated randomization sequence. Blinding will be maintained for both participants and outcome assessors.
Following the establishment of spinal anesthesia, patients will receive either an intravenous loading dose of dexmedetomidine (1 μg/kg) or ketamine (0.15 mg/kg). In both groups, sedation will be maintained with a continuous infusion of dexmedetomidine at a rate of 0.5 μg/kg/h throughout the intraoperative period.
Maternal hemodynamic parameters (including heart rate and blood pressure), sedation levels, patient and surgeon satisfaction scores, neonatal Apgar scores, and perioperative adverse events will be recorded at predefined time points throughout the perioperative period. Standard anesthetic and surgical care will be provided to all participants.
The primary objective of the study is to compare the effects of dexmedetomidine and ketamine on maternal hemodynamic stability. Secondary outcomes include the quality of sedation, patient and surgeon satisfaction, neonatal outcomes, and perioperative adverse events.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Sultangazi
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Istanbul, Sultangazi, Turkey (Türkiye), 34265
- Sultangazi Haseki Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical classification status I patients
- aged >18 years scheduled for cesarean/section surgery under spinal anesthesia were enrolled to the study
Exclusion Criteria:
- known sensitivity or allergy to study drugs
- a history of analgesic or narcotic abuse
- any contraindications for spinal anesthesia
- emergency cesarean/section
- existing of fetal distress.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dexmedetomidine Loading Group (Group D)
Patients received intravenous dexmedetomidine 1 μg/kg over 10 minutes as a loading dose immediately after spinal anesthesia.
|
Maintenance sedation was achieved with dexmedetomidine infusion at 0.5 μg/kg/h after dexmedetomidine loading.
|
|
Active Comparator: Ketamine Loading Group (Group K)
Patients received intravenous ketamine 0.15 mg/kg over 10 minutes as a loading dose immediately after spinal anesthesia.
|
Patients received intravenous ketamine 0.15 mg/kg over 10 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ramsey sedation score
Time Frame: 1)immediately before spinal anesthesia (SA) 2)5 minutes after SA, 3)immediately after the loading dose was completed, 4)immediately before surgical incision, 5)5 minutes after surgical incision, 6)5 minutes after the surgical closure.
|
Sedation score was evaluated by Ramses Sedation Score (RSS). RSS score was as follow: Awake; agitated or restless or both =1 Awake; cooperative, oriented, and tranquil=2 Awake but responds to commands only=3 Asleep; brisk response to light glabellar tap or loud auditory stimulus=4 Asleep; sluggish response to light glabellar tap or loud auditory stimulus=5 Asleep; no response to glabellar tap or loud auditory stimulus=6 |
1)immediately before spinal anesthesia (SA) 2)5 minutes after SA, 3)immediately after the loading dose was completed, 4)immediately before surgical incision, 5)5 minutes after surgical incision, 6)5 minutes after the surgical closure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hemodynamic parameters
Time Frame: In the operating room; from immediately before the induction of anesthesia to transferring to ward with 5 minutes intervals
|
Arterial blood pressure (mmHg), heart rate (beats per mimute)
|
In the operating room; from immediately before the induction of anesthesia to transferring to ward with 5 minutes intervals
|
|
patient and surgeon satisfaction scores
Time Frame: at day 1 postoperatively.
|
Patient and Surgeon satisfaction were evaluated using four-point rating scale: 1=poor, 2=fair, 3=good, 4=excellent.
|
at day 1 postoperatively.
|
|
APGAR score
Time Frame: The Apgar score is assessed at 1 minute and 5 minutes after birth.
|
The score evaluates five parameters, each graded from 0 to 2, for a maximum total of 10 points: Appearance (Skin color): Blue or pale= 0 point, Body pink, extremities blue=1 point, Completely pink=2 points Pulse (Heart rate): Absent=0 point, <100 beats/min (minutes)=1 point, ≥100 beats/min=2 points Grimace (Reflex irritability): No response=0 point, Grimace Cries= 1 point, coughs, or pulls away=2 points Activity (Muscle tone): Limp=0 point, Some flexion=1 point, Active movement=2 points Respiration (Breathing effort): Absent=0 point, Slow or irregular=1 point, Good, strong crying=2 points |
The Apgar score is assessed at 1 minute and 5 minutes after birth.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Halil C Canatan, Ozel Duygu Hastanesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/04-660
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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