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

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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: Placebo; Drug: Pregabalin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Zamalek
    • Cairo, Zamalek, Egypt, 11586
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo group	Drug: Placebo; Placebo
Active Comparator: pregabalin group	Drug: Pregabalin; Pregabalin capsule 150 mg oral; Other Names: laryca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhalational anaesthetic drug requirements	Inhalational anaesthetic requirements to maintain hemodynamic stability (± 20% of the baseline) using MAQUET Flow-I anesthetic machine.	an average of 3 hours after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressor response attenuation	Degree of pressor response attenuation	an average of 10 minutes after induction
First time for analgesics requirement	First time for analgesics requirement.	postoperative (maximum 6 hours after the end of operation)

Collaborators and Investigators

• Sponsor: Nesrine El-Refai

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 20, 2017

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 7, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: General Anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: UTF-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No