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A Comparison Between Propofol and Etomidate in Hysteroscopy on Effect of Postoperative Sedation and Cognitive Function in Elderly Patients

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ClinicalTrials.gov Identifier: NCT02147678
Recruitment Status : Unknown
Verified May 2014 by Wenying Song, Shaanxi Provincial People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 28, 2014
Last Update Posted : May 28, 2014
Sponsor:
Information provided by (Responsible Party):
Wenying Song, Shaanxi Provincial People's Hospital

Brief Summary:
To compare the effect of propofol and etomidate in hysteroscopy on postoperative sedation and cognitive function in elderly patients

Condition or disease Intervention/treatment Phase
Hysteroscopy Hemodynamics Sedation Drug: Etomidate Drug: Propofol Drug: Remifentanil Drug: Anesthesia induction Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group E
Etomidate/remifentanil group. Patients in group E will be given etomidate and remifentanil during the operation, the speeds are 10~15 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
Drug: Etomidate
Other Name: Fu Er Li

Drug: Remifentanil
During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min.

Drug: Anesthesia induction
For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.

Experimental: Group P
Propofol/remifentanil group. Patients in group P will be given propofol and remifentanil during the operation, the speeds are 50~75 μg/kg/min and 0.2~0.4 μg/kg/min, respectively.
Drug: Propofol
Drug: Remifentanil
During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min.

Drug: Anesthesia induction
For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.




Primary Outcome Measures :
  1. Heart rate [ Time Frame: Immediately after the entrance to the operating room until until 60 minutes after the operation ]
    heart rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.

  2. Mean arterial pressure [ Time Frame: Immediately after the entrance to the operating room until until 60 minutes after the operation ]
    Mean arterial pressure will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.

  3. Pulse oxygen saturation [ Time Frame: Immediately after the entrance to the operating room until until 60 minutes after the operation ]
    Pulse oxygen saturation will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.

  4. Respiratory rate [ Time Frame: Immediately after the entrance to the operating room until until 60 minutes after the operation ]
    Respiratory rate will be recorded immediately after the entrance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.

  5. Narcotrend index [ Time Frame: Immediately after the entrance to the operating room until until 60 minutes after the operation ]
    Narcotrend index will be recorded immediately after the entance to the operating room, at the beginning of induction, 2.5 min, 5 min, 7.5 min, 10 min, 15 min, 20 min, 25 min and 30 min after the beginning of induction, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min and 60 min after the operation.


Secondary Outcome Measures :
  1. Cerebral injury parameters [ Time Frame: Immediately after the entrance to the operating room until until 60 minutes after the operation ]
    2 ml blood will be collected immediately after the entrance to the operating room and 60 min after the operation, then SB-100 protein and neuron-specific enolase will be tested by enzyme-linked immunosorbent assay.

  2. Length of stay [ Time Frame: from the date of admission to the day of discharge, expected to 3 days ]
  3. Score of Minimum Mental State Examination [ Time Frame: 1 day before the operation to 45 minutes after the operation ]
    Score of Minimum Mental State Examination will be examined in preoperative visit, 10 minutes, 45 minutes after the operation

  4. Verbal Fluency test [ Time Frame: 1 day before the operation to 60 minutes after the operation ]
    Verbal Fluency test will be examined in preoperative visit and 60 minutes after the operation



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged between 60 and 80 years
  2. Selective hysteroscopic operation
  3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
  4. Signed informed consent form
  5. Expected operation duration is within 60 minutes

Exclusion Criteria:

  1. Serious cardiac, cerebral, liver, kidney, lung, endocrine disease or sepsis
  2. Long use of hormone or history of adrenal suppression
  3. Allergy to trial drug or other contraindication
  4. History or expected difficult airway
  5. Identified, suspected abuse or long use of narcotic analgesia
  6. Neuromuscular diseases
  7. Mentally unstable or has a mental illness
  8. Dysfunction of communication
  9. Trend of malignant hyperthermia
  10. Pregnant or breast-feeding women
  11. Attended other trial past 30 days;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147678


Contacts
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Contact: Wenying Song +86-13609245447 swysong2010@126.com

Sponsors and Collaborators
Shaanxi Provincial People's Hospital

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Responsible Party: Wenying Song, Anesthesiologist, Shaanxi Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT02147678     History of Changes
Other Study ID Numbers: 20140522
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Remifentanil
Anesthetics
Propofol
Etomidate
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents