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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04490980
Other study ID # TJ-C20200119
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date December 31, 2020

Study information

Verified date June 2020
Source Tongji Hospital
Contact Xun Gong, Doctor
Phone 13886174675
Email gongxun4019@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We evaluated the clinical effect of Butorphanol on postoperative analgesia by observing the vital signs of patients, general condition of newborns and pain assessment.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

Healthy women at term (37 to 42 weeks of gestation), who desired cesarean section were eligible to participate. undergoing ;No drug sensitive history

Exclusion Criteria:

Patients with a history of anesthetics allergy and patients with preterm labor, multiple pregnancies and severe obstetric complications

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
butorphanol
Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary change from Visual Analogue Score for pain VAS is the most common pain scale for quantification. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective. Visual analog scale (VAS) ranging from 0 to 10 (with 10 representing the worst pain imaginable) to measure the degree of pain for participants assess VAS at 24 hours, 25 hours, 26 hours, 27 hours, 30 hours, 36 hours after the cesarean section
Secondary heart rates heart rates(bpm) at 24 hours, 30 hours, 36 hours after the cesarean section
Secondary jaundice index of the newborn,1 minute and 5 minutes Apgar score Neonatal Apgar scores at the first and fifth minute.The score indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10. jaundice index: 24 hours, 48 hours, 72 hours after the cesarean section
Secondary blood pressure blood pressure(mmHg) at 24 hours, 30 hours, 36 hours after the cesarean section
Secondary breath breath(bpm) at 24 hours, 30 hours, 36 hours after the cesarean section
Secondary pulse pulse(bpm) at 24 hours, 30 hours, 36 hours after the cesarean section
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