Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Pregabalin
- Conditions
- Hysterectomy
- Sponsor
- Nesrine El-Refai
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Inhalational anaesthetic drug requirements
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Nesrine El-Refai
professor
Cairo University
Eligibility Criteria
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.
Arms & Interventions
pregabalin group
Intervention: Pregabalin
placebo group
Intervention: Placebo
Outcomes
Primary Outcomes
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
- pressor response attenuation(an average of 10 minutes after induction)
- First time for analgesics requirement(postoperative (maximum 6 hours after the end of operation))