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

NCT02208596 | Unknown Phase 4 DMC

• 1 other identifier: 20140729
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Induced Abortion; Anesthesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Efficacy of anesthesia

  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

  from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour

Study Arms (3)

Group A

EXPERIMENTAL

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; Drug: propofol; Drug: Etomidate

Group B

EXPERIMENTAL

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; Drug: propofol; Drug: Etomidate

Group C

EXPERIMENTAL

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; Drug: propofol

Interventions

pentazocine DRUG

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

Group A; Group B; Group C

propofol DRUG

Group A; Group B; Group C

Etomidate DRUG

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Third Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Interventions

Pentazocine; Propofol; Etomidate

Intervention Hierarchy (Ancestors)

Benzomorphans; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 5, 2014

Record last verified: 2014-08