Cesarean Section ComplicationsNCT06017076
Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.
A study testing Oral energy drinks and Warming matress in people with Cesarean Section Complications, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Oral energy drinks and Warming matress
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2023to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, Peking University People's Hospital, 11 Xizhimen South Street, Xicheng District, Beijing, People's Republic of China
Beijing, Beijing Municipality, 100000
About this study
Official 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.
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.
- Conditions
- Cesarean Section Complications
- Being tested
- Oral energy drinks, Warming matress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| warming matress group | Placebo comparator | From the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery. Receives: Device: Warming matress |
| oral functional drinks group | Experimental | Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation. Receives: Other: Oral energy drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature change
The minimum value of intraoperative ear temperature minus the preoperative baseline ear temperature.
Measured: Before the operation, and every 10 minutes during the operation until the end of the operation.
Secondary outcomes (6)
Skin temperature changes
The minimum value of intraoperative skin temperature minus the preoperative baseline skin temperature.
Measured: 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
Measured: Intraoperative
The incidence of nausea in pregnant women
Anesthesiologist observes combined patient dictation.
Measured: Intraoperative
Umbilical artery blood base excess
base excess of fetal umbilical artery blood
Measured: 30sec after delivery
The incidence of vomiting in pregnant women
Anesthesiologist observes combined patient dictation
Measured: Intraoperative
The incidence of shivering in pregnant women
Anesthesiologist observes combined patient dictation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start3 Sep 2023
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017076
- Sponsor's protocol ID
- SFY2023-MZ8-3
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06017076
- Acronym / sponsor ID
- SFY2023-MZ8-3
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warming matress group | Placebo comparator | Device: Warming matressFrom the end of anesthesia, warming matriss at 40 ℃ was used for insulation until the end of surgery. |
| oral functional drinks group | Experimental | Other: Oral energy drinksPatients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral energy drinksPatients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation. | Other | oral functional drinks group |
| Warming matressFrom the end of anesthesia, warming matriss at 40 ℃ was used to keep warm until the end of surgery. | Device | warming matress group |
Primary outcome
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.
6 secondary outcomes
Skin temperature changes
Time frame: Before the operation, and every 10 minutes during the operation until the end of the operation.
hypotension
Time frame: Intraoperative
The incidence of nausea in pregnant women
Time frame: Intraoperative
Umbilical artery blood base excess
Time frame: 30sec after delivery
The incidence of vomiting in pregnant women
Time frame: Intraoperative
The incidence of shivering in pregnant women
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral energy drinks and Warming matress in people with Cesarean Section Complications, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature change (time frame: Before the operation, and every 10 minutes during the operation until the end of the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.