Cesarean BirthPhase 4SedationNCT07676955
Dexmedetomidine Versus Ketamine Loading for Dexmedetomidine Sedation During Elective Cesarean Section Under Spinal Anesthesia
A Phase 4 study testing Dexmedetomidine and Ketamine in people with Cesarean Birth and Spinal Anesthesia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Birth, Spinal Anesthesia, Sedation
- What is being tested?
- Dexmedetomidine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 31 Dec 2021
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultangazi Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Birth, Spinal Anesthesia, Sedation
- Being tested
- Dexmedetomidine, Ketamine
- Keywords
- Cesarean section, spinal anesthesia, Dexmedetomidine, Ketamine, Sedation, Apgar score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Maintenance sedation was achieved with dexmedetomidine infusion at 0.5 μg/kg/h after dexmedetomidine loading.
KetamineDrug
Patients received intravenous ketamine 0.15 mg/kg over 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Loading Group (Group D) | Experimental | Patients received intravenous dexmedetomidine 1 μg/kg over 10 minutes as a loading dose immediately after spinal anesthesia. Receives: 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. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Arterial blood pressure (mmHg), heart rate (beats per mimute)
Measured: In the operating room; from immediately before the induction of anesthesia to transferring to ward with 5 minutes intervals
patient and surgeon satisfaction scores
Patient and Surgeon satisfaction were evaluated using four-point rating scale: 1=poor, 2=fair, 3=good, 4=excellent.
Measured: at day 1 postoperatively.
APGAR score
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
Measured: The Apgar score is assessed at 1 minute and 5 minutes after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Uzman, Haseki Training and Research Hospital
- Investigators
- Halil C Canatan, Principal investigator, Ozel Duygu Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676955
- Sponsor's protocol ID
- 2021/04-660
- Acronym
- Sedation
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
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.
PubMed 29551918