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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03302208
Enrollment
50
Registered
2017-10-05
Start date
2017-06-29
Completion date
2017-09-20
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

Keywords

General Anesthesia

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.

Interventions

DRUGPregabalin

Pregabalin capsule 150 mg oral

DRUGPlacebo

Placebo

Sponsors

Nesrine El-Refai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inhalational anaesthetic drug requirementsan average of 3 hours after inductionInhalational anaesthetic requirements to maintain hemodynamic stability (± 20% of the baseline) using MAQUET Flow-I anesthetic machine.

Secondary

MeasureTime frameDescription
pressor response attenuationan average of 10 minutes after inductionDegree of pressor response attenuation
First time for analgesics requirementpostoperative (maximum 6 hours after the end of operation)First time for analgesics requirement.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026