Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery

Hysteromyoma Clinical Trial

Official title:

Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03524950
• Other study ID #: D to stress study of pituitrin
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2018
• Source: Beijing Anzhen Hospital
• Contact: Xia Cao, M.D.Candidate
• Phone: +86-13811239739
• Email: 13811239739[@]139.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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 a2 agonists.

Related Conditions & MeSH terms

• Hysteromyoma
• Leiomyoma

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acth	adrenocorticotropic hormone	the acth before using pituitrin 5 minutes
Primary	acth	adrenocorticotropic hormone	the acth after using pituitrin 20 minutes
Primary	acth	adrenocorticotropic hormone	the acth after using pituitrin 120 minutes