Anesthesia, Induced Abortion
Conditions
Brief summary
To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.
Interventions
DRUGpentazocine
Every patient enrolled in the study will be given 15 mg pentazocine before induction.
DRUGpropofol
DRUGEtomidate
Sponsors
Third Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | From 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 pressure | From 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 saturation | From 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
| Measure | Time frame | Description |
|---|---|---|
| Aldrete score | 10 min after the opration | — |
| Efficacy of anesthesia | from 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. |
| Satisfaction degree of the patient, the surgeon and the anesthetist | 10 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. |
| 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 | Verbal rating scales of uterine contraction should be recorded at 5 min, 15 min after the operation and before discharge from the hospital |
| 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 | — |
Outcome results
None listed