Status:
UNKNOWN
Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.
Lead Sponsor:
Peking University People's Hospital
Conditions:
Cesarean Section Complications
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
It is not known which is better for intraoperative temperature protection, warming matress or preoperative oral functional drinks in elective cesarean section. We plan to conduct a non inferiority ran...
Eligibility Criteria
Inclusion
- Women pregnant with a single fetus;
- American Society of Anesthesiologists (ASA) physical status II;
- Willingness to undergo elective cesarean delivery under CSEA;
- An age of 20-40 years;
- A body mass index (BMI) of 19-30 kg·m-2;
- A gestational age of 38-40 weeks.
Exclusion
- Contraindications for CSEA;
- A diagnosis of delayed gastric emptying, hyperemesis gravidarum until late pregnancy, or consumption of drugs that affect gastrointestinal motility within 3 days before surgery;
- Preoperative body temperature \>38°C or \<36°C or the use of drugs that affect body temperature;
- Pregnancy combined with diabetes, hypertension, or metabolic disorders (eg, hypothyroidism or hyperthyroidism);
- Ear diseases (eg, otitis media, tympanic membrane perforation, etc) affecting measurement of ear temperature .
- Patients who were simultaneously undergoing other operations (eg, removal of uterine fibroids and ovarian cysts) or had a surgical time \>1.5 hours;
- Patients with blood transfusion or autologous blood transfusion intraoperatively;
- Patients who did not receive the anesthetic specified in the protocol;
- Patients who failed to drink adequate energy drinks as prescribed before surgery.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06017076
Start Date
September 1 2023
End Date
December 1 2024
Last Update
August 30 2023
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