Back to resultsEffect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
Primary Purpose
Hysteromyoma
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Hysteromyoma focused on measuring stress, dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index.
Exclusion Criteria:
Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
no dexmedetomidine
high dose dexmedetomidine
low dose dexmedetomidine
Arm Description
Outcomes
Primary Outcome Measures
acth
adrenocorticotropic hormone
acth
adrenocorticotropic hormone
acth
adrenocorticotropic hormone
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03524950
Brief Title
Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
Official Title
Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteromyoma
Keywords
stress, dexmedetomidine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no dexmedetomidine
Arm Type
No Intervention
Arm Title
high dose dexmedetomidine
Arm Type
Experimental
Arm Title
low dose dexmedetomidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Ninety patients will be assigned to three groups. Group A add saline in general anesthesia laparoscopic hysteromyoma surgery. Group B add dexmedetomidine 1μg/Kg10minutes as loading dose, followed by 0.7μg/Kg/h for maintenance.Group C add dexmedetomidine 0.7μg/Kg10minutes as loading dose, followed by 0.5μg/Kg/h for maintenance.
Primary Outcome Measure Information:
Title
acth
Description
adrenocorticotropic hormone
Time Frame
the acth before using pituitrin 5 minutes
Title
acth
Description
adrenocorticotropic hormone
Time Frame
the acth after using pituitrin 20 minutes
Title
acth
Description
adrenocorticotropic hormone
Time Frame
the acth after using pituitrin 120 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index.
Exclusion Criteria:
Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia Cao, M.D.Candidate
Phone
+86-13811239739
Email
13811239739@139.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
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