Pregabalin Reduce the Sevoflurane Requirement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed R El Tahan, Mansoura University
ClinicalTrials.gov Identifier:
NCT01571804
First received: March 31, 2012
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Elective Laparoscopic Cholecystectomy
Sevoflurane Anesthesia
Drug: Placebo
Drug: pregabalin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.

Resource links provided by NLM:


Further study details as provided by Mansoura University:

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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • intraoperative fentanyl supplementations [ Time Frame: intraoperative, an expected average of 2 hours ] [ Designated as safety issue: No ]
    intraoperative fentanyl supplementations

  • quality of tracheal extubation [ Time Frame: up to 24 after surgery ] [ Designated as safety issue: No ]
    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

  • postoperative cumulative morphine consumption [ Time Frame: up to 24 after surgery ] [ Designated as safety issue: No ]
    postoperative cumulative morphine consumption

  • postoperative sedation and pain scores [ Time Frame: up to 24 after surgery ] [ Designated as safety issue: No ]
    Postoperative pain VAS scores sedation (four-point verbal rating scores (VRS): awake, drowsy, rousable or deep sleep)

  • postoperative nausea and vomiting [ Time Frame: up to 24 after surgery ] [ Designated as safety issue: Yes ]
    nausea and vomiting (0: no nausea; 1: nausea no vomiting; 2: nausea and vomiting)

  • awareness and recall [ Time Frame: intraoperative, an expected average of 2 hours ] [ Designated as safety issue: Yes ]
    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?"


Enrollment: 42
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01571804

Locations
Egypt
Mansoura University Hospitals
Mansoura, DK, Egypt, 050
Sponsors and Collaborators
Mansoura University
  More Information

No publications provided

Responsible Party: Mohamed R El Tahan, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT01571804     History of Changes
Other Study ID Numbers: R/49
Study First Received: March 31, 2012
Last Updated: May 4, 2012
Health Authority: Egypt: Ministry of Higher Education

Keywords provided by Mansoura University:
Anesthesia
pregabalin
sevoflurane
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Sevoflurane
Pregabalin
Gamma-Aminobutyric Acid
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014