NCT06017076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 3, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2025

Completed
Last Updated

January 21, 2026

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

August 24, 2023

Last Update Submit

January 17, 2026

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Skin temperature changes

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

  • hypotension

    Intraoperative

  • The incidence of nausea in pregnant women

    Intraoperative

  • Umbilical artery blood base excess

    30sec after delivery

  • The incidence of vomiting in pregnant women

    Intraoperative

  • +1 more secondary outcomes

Study Arms (2)

warming matress group

PLACEBO COMPARATOR

From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery.

Device: Warming matress

oral functional drinks group

EXPERIMENTAL

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

Other: Oral energy drinks

Interventions

Oral energy drinksOTHER

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

oral functional drinks group
Warming matressDEVICE

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

warming matress group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of anesthesiology

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

September 3, 2023

Primary Completion

November 25, 2025

Study Completion

November 25, 2025

Last Updated

January 21, 2026

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Locations

CN(1)