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Pregabalin Reduce the Sevoflurane Requirement

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ClinicalTrials.gov Identifier: NCT01571804
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : May 7, 2012
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Elective Laparoscopic Cholecystectomy Sevoflurane Anesthesia Drug: Placebo Drug: pregabalin Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.
Study Start Date : December 2011
Primary Completion Date : February 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: pregabalin 150 mg group
one capsule of pregabalin 150 mg and one placebo capsule
Drug: pregabalin
one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery
Active Comparator: pregabalin 300 mg group
two capsules of pregabalin 150 mg
Drug: pregabalin
two capsules of pregabalin 150 mg 1 hr before surgery
Placebo Comparator: placebo group
to receive two identical placebo capsules
Drug: Placebo
to receive two identical placebo capsules 1 hr before surgery

Primary Outcome Measures :
  1. changes in the end tidal sevoflurane concentrations [ Time Frame: intraoperative every 15 min ]
    End-tidal concentrations of sevoflurane (Et-Sevo) were recorded every 15 min after intubation until the skin closure.

Secondary Outcome Measures :
  1. hemodynamic parameters [ Time Frame: before surgery, after the administration of the study capsules; intraoperative, an expected average of 2 hours, up to 24 after surgery ]
    heart rate and mean arterial blood pressure were recorded before (baseline), 45 min after the administration of the study capsules; every 15 min after intubation until the skin closure and every 15 min for the first hour after extubation.

  2. intraoperative fentanyl supplementations [ Time Frame: intraoperative, an expected average of 2 hours ]
    intraoperative fentanyl supplementations

  3. quality of tracheal extubation [ Time Frame: up to 24 after surgery ]
    The quality of tracheal extubation was evaluated using a 5 - points rating scale: 1, no coughing or straining; 2, very smooth, minimal coughing; 3, moderate coughing; 4, marked coughing or straining; and 5, poor extubation, very uncomfortable

  4. postoperative cumulative morphine consumption [ Time Frame: up to 24 after surgery ]
    postoperative cumulative morphine consumption

  5. postoperative sedation and pain scores [ Time Frame: up to 24 after surgery ]
    Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep)

  6. postoperative nausea and vomiting [ Time Frame: up to 24 after surgery ]
    nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)

  7. awareness and recall [ Time Frame: intraoperative, an expected average of 2 hours ]
    The patients were asked about intraoperative awareness and recall on the second postoperative day by asking three simple questions using standard interview "What was the last thing you remembered happening before you went to sleep? What is the first thing you remember happening on waking? Did you dream or have any other experiences whilst you were asleep?"

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571804

Mansoura University Hospitals
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University

Responsible Party: Mohamed R El Tahan, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT01571804     History of Changes
Other Study ID Numbers: R/49
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Mohamed R El Tahan, Mansoura University:
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs