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

Phase 4
Conditions
Induced Abortion
Anesthesia
Interventions
Registration Number
NCT02208596
Lead Sponsor
Third Affiliated Hospital of Zhengzhou University
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
150
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group ApentazocineIn 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.
Group ApropofolIn 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.
Group BpentazocineIn 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.
Group AEtomidateIn 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.
Group CpentazocineIn 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.
Group BpropofolIn 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.
Group BEtomidateIn 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.
Group CpropofolIn 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.
Primary Outcome Measures
NameTimeMethod
Heart rateFrom baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection

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.

Blood pressureFrom baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection

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.

Pulse oxygen saturationFrom baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection

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.

Secondary Outcome Measures
NameTimeMethod
Use of specific medicationsfrom the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour
Dose of propofol or mixture of propofol and etomidatefrom 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
Aldrete score10 min after the opration
Satisfaction degree of the patient, the surgeon and the anesthetist10 min before discharge from the hospital

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.

Efficacy of anesthesiafrom baseline to discharge from the hospital, expected to no more than 1 hour

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.

Verbal rating scales of uterine contractionfrom 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour

Verbal rating scales of uterine contraction should be recorded at 5 min, 15 min after the operation and before discharge from the hospital

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