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NCT Number: NCT03302208

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

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.

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Key information

Conditions

Hysterectomy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University

Cairo, Zamalek, 11586, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pregabalin

Drug

Pregabalin capsule 150 mg oral

Other names: laryca

Placebo

Drug

Placebo

Primary outcomes

  1. Inhalational anaesthetic drug requirements

    Time frame: an average of 3 hours after induction

    Inhalational anaesthetic requirements to maintain hemodynamic stability (± 20% of the baseline) using MAQUET Flow-I anesthetic machine.

Secondary outcomes

  1. pressor response attenuation

    Time frame: an average of 10 minutes after induction

    Degree of pressor response attenuation

  2. First time for analgesics requirement

    Time frame: postoperative (maximum 6 hours after the end of operation)

    First time for analgesics requirement.

Sponsors and collaborators

Lead sponsor

Nesrine El-Refai

Other

Registry information

Official study title

Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2017
Registry last updated
Jan 9, 2018

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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