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

Ling Dong

Status and phase: Enrolling; Phase 4

Conditions: Analgesia, Patient-Controlled; Cesarean Section; S-ketamine

Treatments: Drug: S-ketamine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05299866

YXLL-KY-2021(071)

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups, including a placebo group

S-ketamine group

Experimental group

Description:

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

Treatment:

Drug: S-ketamine

Control group

Placebo Comparator group

Description:

The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.

Treatment:

Drug: Placebo