Cesarean Section Complications
Conditions
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.
Interventions
OTHEROral energy drinks
Patients drank energy drinks (Red Bull®) 250ml about 2-2.5 hours before operation.
DEVICEWarming matress
From the end of anesthesia, warming matriss at 40 ℃ was used to keep warm until the end of surgery.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core temperature change | 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
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature changes | 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. |
| hypotension | Intraoperative | Number of Participants with systolic blood pressure reduction \>20% baseline value or systolic blood pressure \<90 mm Hg before delivery |
| The incidence of nausea in pregnant women | Intraoperative | Anesthesiologist observes combined patient dictation. |
| Umbilical artery blood base excess | 30sec after delivery | base excess of fetal umbilical artery blood |
| The incidence of vomiting in pregnant women | Intraoperative | Anesthesiologist observes combined patient dictation |
| The incidence of shivering in pregnant women | Intraoperative | Anesthesiologist observes combined patient dictation |
Countries
China
Outcome results
None listed