CClinicalTrials.gg
Status unknownNCT02208596Updated Aug 5, 2014

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

A Phase 4 interventional study of pentazocine and propofol in Induced Abortion and Anesthesia, sponsored by Third Affiliated Hospital of Zhengzhou University. Status unknown. Open to participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2014-08-05.

Sponsored by Third Affiliated Hospital of Zhengzhou University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Induced Abortion
  • Anesthesia
03

In context

Lead sponsor

Third Affiliated Hospital of Zhengzhou University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • 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: pentazocine · Drug: propofol · Drug: Etomidate

  • 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: pentazocine · Drug: propofol · Drug: Etomidate

  • 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: pentazocine · Drug: propofol

Interventions

  • Drugpentazocine

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

  • Drugpropofol
  • DrugEtomidate
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

  3. Use of specific medications

    Time frame: from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour

  4. Aldrete score

    Time frame: 10 min after the opration

  5. 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

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

  6. 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.

    Time frame: 10 min before discharge from the hospital

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02208596
Lead sponsor
Third Affiliated Hospital of Zhengzhou University
Responsible party
Sponsor
First posted
Aug 5, 2014
Start date
Sep 2014
Primary completion
Feb 2015 (estimated)
Completion
Feb 2015 (estimated)
Last update
Aug 5, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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