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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Other: Oral energy drinks
* Device: Warming matress


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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. | 
| hypotension | Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery | Intraoperative | 
| The incidence of nausea in pregnant women | Anesthesiologist observes combined patient dictation. | Intraoperative | 
| Umbilical artery blood base excess | base excess of fetal umbilical artery blood | 30sec after delivery | 
| The incidence of vomiting in pregnant women | Anesthesiologist observes combined patient dictation | Intraoperative | 
| The incidence of shivering in pregnant women | Anesthesiologist observes combined patient dictation | Intraoperative |