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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02208596
Other study ID # 20140729
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 1, 2014
Last updated August 3, 2014
Start date September 2014
Est. completion date February 2015

Study information

Verified date August 2014
Source Third Affiliated Hospital of Zhengzhou University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- Aged between 20 and 35 years

- American Society of Anesthesiology (ASA) Physical Status: ? or ?

- Singleton pregnancy and the gestational period is 6 to 8 weeks

- Expected operation duration is within 60 minutes

- The body weight should be within 15% around the standard weight

- Signed informed consent form

Exclusion Criteria:

- Serious cardiac, cerebral, liver, kidney, lung, endocrine disease

- Upper respiratory infections within 4 weeks

- Long use of hormone or history of adrenal suppression

- History of use of glucocorticoids, aprotinin or immunosuppressant

- Manifestation of immunodeficiency

- History of use of sedatives or opiates

- Needs of Neuromuscular blocker (except intubation)

- Allergy to trial drug or other contraindication

- Pregnant or breast-feeding women

- Attended other trial past 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
pentazocine
Every patient enrolled in the study will be given 15 mg pentazocine before induction.
propofol

Etomidate


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Third Affiliated Hospital of Zhengzhou University

Outcome

Type Measure Description Time frame Safety issue
Primary Heart rate Heart rate will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate. From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection Yes
Primary Blood pressure Blood pressure will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate. From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection Yes
Primary Pulse oxygen saturation Pulse oxygen saturation will be recorded immediately when the patient arrived at the operating room, 2 min, 4 min, 6 min, 8 min and 10 minutes after the the injection of propofol or mixture of propofol and etomidate. From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection Yes
Secondary Efficacy of anesthesia The following point-in-time will be recorded to calculated the period from the injection of propofol or mixture of propofol and etomidate: disappearance of eyelash reflex, injection of supplementary propofol or mixture of propofol and etomidate, awaking, obeying commands, discharge. Anesthesia time was defined as the period from disappearance of eyelash reflex to awaking. from baseline to discharge from the hospital, expected to no more than 1 hour No
Secondary Dose of propofol or mixture of propofol and etomidate from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min No
Secondary Use of specific medications from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour No
Secondary Aldrete score 10 min after the opration No
Secondary Verbal rating scales of uterine contraction Verbal rating scales of uterine contraction should be recorded at 5 min, 15 min after the operation and before discharge from the hospital from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour No
Secondary Satisfaction degree of the patient, the surgeon and the anesthetist Satisfaction degree will be rated as excellent, good and poor based on a scale of 1 to 10. Excellent is 8 to 10, good is 5 to 7 and poor is 1 to 4. 10 min before discharge from the hospital No
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