Cesarean Section Complications Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 280 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Peking University People's Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | hypotension | Number of Participants with systolic blood pressure reduction >20% baseline value or systolic blood pressure <90 mm Hg before delivery | Intraoperative | |
Secondary | The incidence of nausea in pregnant women | Anesthesiologist observes combined patient dictation. | Intraoperative | |
Secondary | Umbilical artery blood base excess | base excess of fetal umbilical artery blood | 30sec after delivery | |
Secondary | The incidence of vomiting in pregnant women | Anesthesiologist observes combined patient dictation | Intraoperative | |
Secondary | The incidence of shivering in pregnant women | Anesthesiologist observes combined patient dictation | Intraoperative |
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