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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06017076
• Other study ID #: SFY2023-MZ8-3
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: August 2023
• Source: Peking University People's Hospital
• Contact: Yi Feng
• Phone: 13601083503
• Email: doctor_yifeng[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Device:
• Warming matress
From the end of anesthesia, warming matriss at 40 ? was used to keep warm until the end of surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

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