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Completed

NCT Number: NCT06017076

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

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.

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Key information

Conditions

Cesarean Section Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral energy drinks

Other

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

Warming matress

Device

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

Primary outcomes

  1. Core temperature change

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

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

Secondary outcomes

  1. Skin temperature changes

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

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

  2. hypotension

    Time frame: Intraoperative

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

  3. The incidence of nausea in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation.

  4. Umbilical artery blood base excess

    Time frame: 30sec after delivery

    base excess of fetal umbilical artery blood

  5. The incidence of vomiting in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation

  6. The incidence of shivering in pregnant women

    Time frame: Intraoperative

    Anesthesiologist observes combined patient dictation

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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