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

Phase 4UnknownNCT02208596

Third Affiliated Hospital of Zhengzhou University150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Induced Abortion Anesthesia

Interventions

pentazocineDRUG

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

propofolDRUG

EtomidateDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection

Secondary Outcomes

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.

Time frame: from baseline to discharge from the hospital, expected to no more than 1 hour

Dose of propofol or mixture of propofol and etomidate

Time frame: 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

Data from ClinicalTrials.gov

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