Clinical trial

The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section

Name

YXLL-KY-2021(071)

Description

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.

Trial arms

Trial start

2022-04-12

Estimated PCD

2024-05-31

Trial end

2024-06-30

Status

Recruiting

Phase

Early phase I

Treatment

S-ketamine

After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.

Arms:

S-ketamine group

Placebo

After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.

Arms:

Control group

Size

216

Primary endpoint

The percentage of patients with moderate-to-severe pain

Up to 48 hours after surgery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 216, 'type': 'ESTIMATED'}}

Updated at

2023-02-28

1 organization

1 product

1 drug

4 indications

Organization

Ling Dong

Product

S-ketamine

Indication

S-ketamine