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

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

Conditions
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Induced Abortion, Anesthesia

Intervention / Treatment
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* Drug: pentazocine
* Drug: propofol
* Drug: Etomidate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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: pentazocine<br>* Every patient enrolled in the study will be given 15 mg pentazocine before induction.<br>Drug: propofol<br> <br> Drug: Etomidate<br> <br> |
| Experimental: Group B<br>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: pentazocine<br>* Every patient enrolled in the study will be given 15 mg pentazocine before induction.<br>Drug: propofol<br> <br> Drug: Etomidate<br> <br> |
| Experimental: Group C<br>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: pentazocine<br>* Every patient enrolled in the study will be given 15 mg pentazocine before induction.<br>Drug: propofol<br> <br> |

What is the study measuring?
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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 |