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Completed

NCT Number: NCT01571804

Pregabalin Reduce the Sevoflurane Requirement

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.

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Key information

Conditions

Elective Laparoscopic Cholecystectomy Sevoflurane Anesthesia

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University Hospitals

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

to receive two identical placebo capsules 1 hr before surgery

Pregabalin

Drug

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

Primary outcomes

  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 outcomes

  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?"

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 5, 2012
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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