Cesarean Birth, Sedation, Spinal Anesthesia
Conditions
Keywords
Cesarean section, spinal anesthesia, Dexmedetomidine, Ketamine, Sedation, Apgar score
Brief summary
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.
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.
Interventions
DRUGDexmedetomidine
Maintenance sedation was achieved with dexmedetomidine infusion at 0.5 μg/kg/h after dexmedetomidine loading.
DRUGKetamine
Patients received intravenous ketamine 0.15 mg/kg over 10 minutes
Sponsors
Haseki Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ramsey sedation score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hemodynamic parameters | 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) |
| patient and surgeon satisfaction scores | at day 1 postoperatively. | Patient and Surgeon satisfaction were evaluated using four-point rating scale: 1=poor, 2=fair, 3=good, 4=excellent. |
| APGAR score | 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 |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORHalil C Canatan
Ozel Duygu Hastanesi
Outcome results
None listed