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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hysteromyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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no dexmedetomidine

Group Type NO_INTERVENTION

No interventions assigned to this group

high dose dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

low dose dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes