The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial

Anesthesia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02208596
• Other study ID #: 20140729
• 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

• Anesthesia
• Induced Abortion

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