Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.

Peking University

Status: Completed

Conditions: Cesarean Section Complications

Treatments: Device: Warming matress; Other: Oral energy drinks

Study type: Interventional

Funder types: Other

Identifiers

NCT06017076

SFY2023-MZ8-3

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups, including a placebo group

warming matress group

Placebo Comparator group

Description:

From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.

Treatment:

Device: Warming matress

oral functional drinks group

Experimental group

Description:

Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.

Treatment:

Other: Oral energy drinks