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

Not Applicable

Not yet recruiting

• Conditions: Cesarean Section Complications
• Interventions: Device: Warming matress; Other: Oral energy drinks

• Registration Number: NCT06017076
• Lead Sponsor: Peking University People's Hospital

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 randomized trial to clarify this problem.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Study First Posted: 2023-08-30
• Last Update Posted: 2023-08-30
• Study Start: 2023-09-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
warming matress group	Warming matress	From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.
oral functional drinks group	Oral energy drinks	Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.

Primary Outcome Measures

Name	Time	Method
Core temperature change	Before the operation, and every 10 minutes during the operation until the end of the operation.	The minimum value of intraoperative ear temperature minus the preoperative baseline ear temperature.

Secondary Outcome Measures

Name	Time	Method
The incidence of nausea in pregnant women	Intraoperative	Anesthesiologist observes combined patient dictation.
hypotension	Intraoperative	Number of Participants with systolic blood pressure reduction \>20% baseline value or systolic blood pressure \<90 mm Hg before delivery
Umbilical artery blood base excess	30sec after delivery	base excess of fetal umbilical artery blood
Skin temperature changes	Before the operation, and every 10 minutes during the operation until the end of the operation.	The minimum value of intraoperative skin temperature minus the preoperative baseline skin temperature.
The incidence of vomiting in pregnant women	Intraoperative	Anesthesiologist observes combined patient dictation
The incidence of shivering in pregnant women	Intraoperative	Anesthesiologist observes combined patient dictation