Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During … (NCT06017076) | Clinical Trial Compass
CompletedNot Applicable
Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.
China302 participantsStarted 2023-09-03
Plain-language 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 randomized trial to clarify this problem.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women pregnant with a single fetus;
* American Society of Anesthesiologists (ASA) physical status II;
* Willingness to undergo elective cesarean delivery under combined spinal-epidural anesthesia;
* A body mass index (BMI) \< 35 kg·m-2;
* A gestational age of 38-40 weeks.
Exclusion Criteria:
* Contraindications for combined spinal-epidural anesthesia;
* 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;
* Intraoperative malfunction of the warming blanket;
* 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 125ml energy drinks before surgery.
What they're measuring
1
Core temperature change
Timeframe: Before the operation, and every 10 minutes during the operation until the end of the operation.