Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
May 15, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMay 15, 2018
May 1, 2018
1.6 years
May 2, 2018
May 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
acth
adrenocorticotropic hormone
the acth before using pituitrin 5 minutes
acth
adrenocorticotropic hormone
the acth after using pituitrin 20 minutes
acth
adrenocorticotropic hormone
the acth after using pituitrin 120 minutes
Study Arms (3)
no dexmedetomidine
NO INTERVENTIONhigh dose dexmedetomidine
EXPERIMENTALlow dose dexmedetomidine
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- student
Study Record Dates
First Submitted
May 2, 2018
First Posted
May 15, 2018
Study Start
June 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
May 15, 2018
Record last verified: 2018-05