Preoperative Oral Pregabalin Effect on Inhalational Anesthetic Requirements ln Hysterectomy Under General Anesthesia

NCT ID: NCT03302208

Last Updated: 2018-01-09

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2017-09-20

Brief Summary

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In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) may be effective in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II , aged 18-60 years, schedule for elective abdominal hysterectomy surgery under general anesthesia.

Detailed Description

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In this study the investigators hypothesized that preoperative pregabalin tablet (150 mg orally ) would be effective in reducing intraoperative isoflurane requirement needed to maintain intraoperative hemodynamics within ± 20% of baseline measurement and/or attenuates hemodynamic response to endotracheal intubation in female patients ASA I or II schedule for elective abdominal hysterectomy surgery under general anaesthesia.

The investigators aim to compare the efficacy of preoperative oral pregabalin versus placebo in reducing intraoperative isoflurane requirements needed to maintain intraoperative hemodynamic stability (Blood pressure and heart rate within ± 20% of baseline measurements) in female patients ASA I/II undergoing elective abdominal hysterectomy surgery under general anaesthesia.

Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pregabalin group

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type DRUG

Pregabalin capsule 150 mg oral

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Pregabalin

Pregabalin capsule 150 mg oral

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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laryca

Eligibility Criteria

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Inclusion Criteria

* Female patients, aged 18-60 year scheduled for elective abdominal hysterectomy surgery under general anaesthesia.
* American Society of Anaesthesiology (ASA) physical status I or II.

Exclusion Criteria

* American Society of Anaesthesiology (ASA) physical status ≥ III.
* Allergy or hypersensitivity to pregabalin.
* Patient on calcium channel blocker or anticonvulsant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nesrine El-Refai

OTHER

Sponsor Role lead

Responsible Party

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Nesrine El-Refai

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cairo University

Cairo, Zamalek, Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UTF-9

Identifier Type: -

Identifier Source: org_study_id

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