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

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Induced Abortion
• Intervention / Treatment: Drug: propofol; Drug: Etomidate; Drug: pentazocine

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged between 20 and 35 years
• American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; In group A, propofol (1%) was mixed with etomidate in the ration of 1:1 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.	Drug: propofol; Drug: Etomidate; Drug: pentazocine; Every patient enrolled in the study will be given 15 mg pentazocine before induction.
Experimental: Group B; In group B, propofol (1%) was mixed with etomidate in the ration of 7:5 (volume). The mixture will be injected continuously until the eyelash reflex disappears. During the operation, supplementary mixture will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.	Drug: propofol; Drug: Etomidate; Drug: pentazocine; Every patient enrolled in the study will be given 15 mg pentazocine before induction.
Experimental: Group C; In group C, propofol (1%) will be injected continuously until the eyelash reflex disappears. During the operation, supplementary propofol will be administered if the patient has spontaneous movement that hampered the conduct of the procedure.	Drug: propofol; Drug: pentazocine; Every patient enrolled in the study will be given 15 mg pentazocine before induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Aldrete score		10 min after the opration
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
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

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 3, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: August 3, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Narcotic Antagonists; Propofol; Etomidate; Pentazocine
• Other Study ID Numbers: 20140729