Pregabalin Reduce the Sevoflurane Requirement

NCT ID: NCT01571804

Last Updated: 2012-05-07

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

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-03-31

Brief Summary

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Preoperative administration of pregabalin would reduce the end tidal concentration of sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the quality of postoperative analgesia.

Detailed Description

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laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the presynaptic voltage-gated calcium channels that are widely distributed throughout the central and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating, anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin, dopamine and substance P. These unique characteristics make pregabalin as a useful therapeutic for treating neuropathic pain and acute postoperative pain in several models of incisional injury and inflammatory conditions including laparoscopic cholecystectomy.

Conditions

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Elective Laparoscopic Cholecystectomy Sevoflurane Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pregabalin 150 mg group

one capsule of pregabalin 150 mg and one placebo capsule

Group Type ACTIVE_COMPARATOR

pregabalin

Intervention Type DRUG

one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery

pregabalin 300 mg group

two capsules of pregabalin 150 mg

Group Type ACTIVE_COMPARATOR

pregabalin

Intervention Type DRUG

two capsules of pregabalin 150 mg 1 hr before surgery

placebo group

to receive two identical placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

to receive two identical placebo capsules 1 hr before surgery

Interventions

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Placebo

to receive two identical placebo capsules 1 hr before surgery

Intervention Type DRUG

pregabalin

one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery

Intervention Type DRUG

pregabalin

two capsules of pregabalin 150 mg 1 hr before surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists class I and II
* scheduled for elective laparoscopic cholecystectomy
* under sevoflurane anesthesia

Exclusion Criteria

* communication barriers
* cardiovascular diseases
* renal diseases
* hepatic diseases
* endocrinal diseases
* neuropsychiatric diseases
* prolonged P-R interval
* pregnancy
* nursing
* hypersensitivity
* treated by pregabalin, antidepressant, anticonvulsants, opiates or benzodiazepines during the last week
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed R El Tahan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University Hospitals

Al Mansurah, DK, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R/49

Identifier Type: -

Identifier Source: org_study_id

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