The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section

Phase 4

Recruiting

• Conditions: Cesarean Section; S-ketamine; Analgesia, Patient-Controlled
• Interventions: Drug: Placebo; Drug: S-ketamine

• Registration Number: NCT05299866
• Lead Sponsor: Ling Dong

Brief Summary

This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-26
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2022-04-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-25
• Last Update Posted: 2023-02-28
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status II
• Patients aged between 20 and 40 years
• 18 kg/m² ≤BMI≤30 kg/m²
• singleton term pregnancy
• scheduled for elective cesarean section

Exclusion Criteria

• Refused to participant in this trial
• Severe heart dysfunction or pulmonary insufficiency
• Poor blood pressure control in those with hypertension (BP >160/100 mmHg in the ward)
• Previous history of Intracranial hypertension or hyperthyroidism
• Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium
• Allergy to drugs used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.
S-ketamine group	S-ketamine	The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.

Primary Outcome Measures

Name	Time	Method
The percentage of patients with moderate-to-severe pain	Up to 48 hours after surgery	Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4.

Secondary Outcome Measures

Name	Time	Method
NRS pain score at rest and with movement	Hour 12 & Hour 24 & Hour 48 after surgery	Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)

Trial Locations

Locations (1)

Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China