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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Device: Warming matress; Other: Oral energy drinks

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Feng; Phone Number: 13601083503; Email: doctor_yifeng@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: warming matress group; From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.	Device: Warming matress; From the end of anesthesia, warming matriss at 40 ℃ was used to keep warm until the end of surgery.
Experimental: oral functional drinks group; Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.	Other: Oral energy drinks; Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of nausea in pregnant women	Anesthesiologist observes combined patient dictation.	Intraoperative
The incidence of vomiting in pregnant women	Anesthesiologist observes combined patient dictation	Intraoperative
hypotension	Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery	Intraoperative
Umbilical artery blood base excess	base excess of fetal umbilical artery blood	30sec after delivery
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.
The incidence of shivering in pregnant women	Anesthesiologist observes combined patient dictation	Intraoperative

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SFY2023-MZ8-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No