Analgesia, Patient-Controlled, Cesarean Section, S-ketamine
Conditions
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.
Interventions
DRUGS-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.
DRUGPlacebo
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.
Sponsors
Ling Dong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The total number of presses of Patient-controlled Analgesia (PCA) | Up to 48 hours after surgery | The total number of presses of PCA |
| The percentage of using rescue analgesics | Up to 48 hours after surgery | The percentage of using rescue analgesics |
| The Richmond Agitation-Sedation Scale(RASS) | Hour 12 & Hour 24 & Hour 48 after surgery | Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4) |
| The incidence of postoperative adverse event | Up to 48 hours after surgery | postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc |
Countries
China
Contacts
Primary ContactLing Dong, Ph.D
Backup ContactLing Dong, MD
Outcome results
None listed