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

Peking University People's Hospital302 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

302

Conditions

Cesarean Section Complications

Interventions

Oral energy drinksOTHER

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

Warming matressDEVICE

From the end of anesthesia, warming matriss at 40 ℃ was used to keep warm until the end of surgery.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Anesthesiology, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, People's Republic of China

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Core temperature change

The minimum value of intraoperative ear temperature minus the preoperative baseline ear temperature.

Time frame: Before the operation, and every 10 minutes during the operation until the end of the operation.

Secondary Outcomes

Skin temperature changes

The minimum value of intraoperative skin temperature minus the preoperative baseline skin temperature.

Time frame: Before the operation, and every 10 minutes during the operation until the end of the operation.

hypotension

Number of Participants with systolic blood pressure reduction \>20% baseline value or systolic blood pressure \<90 mm Hg before delivery

Time frame: Intraoperative

The incidence of nausea in pregnant women

Anesthesiologist observes combined patient dictation.

Time frame: Intraoperative

Umbilical artery blood base excess

base excess of fetal umbilical artery blood

Time frame: 30sec after delivery

The incidence of vomiting in pregnant women

Anesthesiologist observes combined patient dictation

Time frame: Intraoperative

The incidence of shivering in pregnant women

Anesthesiologist observes combined patient dictation

Time frame: Intraoperative

Data from ClinicalTrials.gov

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