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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: S-ketamine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-ketamine group<br>The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. | Drug: S-ketamine<br>* 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.<br>|
| Placebo Comparator: Control group<br>The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with moderate-to-severe pain | 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. | Up to 48 hours after surgery | 

Secondary Outcome Measures

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