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

NCT07676955 | Completed Phase 4 DMC

• 1 other identifier: 2021/04-660
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Birth; Spinal Anesthesia; Sedation

Keywords

Cesarean section; spinal anesthesia; Dexmedetomidine; Ketamine; Sedation; Apgar score

Outcome Measures

Primary Outcomes (1)

• Ramsey sedation score

  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 Outcomes (3)

• hemodynamic parameters

  In the operating room; from immediately before the induction of anesthesia to transferring to ward with 5 minutes intervals

• patient and surgeon satisfaction scores

  at day 1 postoperatively.

• APGAR score

  The Apgar score is assessed at 1 minute and 5 minutes after birth.

Study Arms (2)

Dexmedetomidine Loading Group (Group D)

EXPERIMENTAL

Patients received intravenous dexmedetomidine 1 μg/kg over 10 minutes as a loading dose immediately after spinal anesthesia.

Drug: Dexmedetomidine

Ketamine Loading Group (Group K)

ACTIVE COMPARATOR

Patients received intravenous ketamine 0.15 mg/kg over 10 minutes as a loading dose immediately after spinal anesthesia.

Drug: Ketamine

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine Loading Group (Group D)

Ketamine DRUG

Patients received intravenous ketamine 0.15 mg/kg over 10 minutes

Ketamine Loading Group (Group K)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female, parturients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Sultangazi Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Related Publications (1)

• Zhao ZY, Gan JH, Liu JB, Cheng Q. Clinical evaluation of combination of dexmedetomidine and midazolam vs. dexmedetomidine alone for sedation during spinal anesthesia. Saudi J Biol Sci. 2017 Dec;24(8):1758-1762. doi: 10.1016/j.sjbs.2017.11.007. Epub 2017 Nov 9.

  PMID: 29551918 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Halil C Canatan

  Ozel Duygu Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate prof.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 months and ending 36 months following article publication.
• Access Criteria: Proposals should be directed to drsinanuzman@yahoo.com

Locations

TU (1)