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

Phase 3

Completed

• Conditions: Hysterectomy
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT03302208
• Lead Sponsor: Nesrine El-Refai

Brief Summary

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.

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 Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2017-06-29
• Primary Completion: 2017-09-01
• Study Completion: 2017-09-20
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-07
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	-
pregabalin group	Pregabalin	-

Primary Outcome Measures

Name	Time	Method
Inhalational anaesthetic drug requirements	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 Outcome Measures

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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Zamalek, Egypt