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NCT Number: NCT07676955

Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia

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.

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Key information

Conditions

Cesarean Birth Sedation Spinal Anesthesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sultangazi Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Dexmedetomidine

Drug

Maintenance sedation was achieved with dexmedetomidine infusion at 0.5 μg/kg/h after dexmedetomidine loading.

ketamine

Drug

Patients received intravenous ketamine 0.15 mg/kg over 10 minutes

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia: A Prospective Randomized Double-Blind Trial

Acronym: Sedation

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2026
Registry last updated
Jun 30, 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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