NCT03302208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

June 29, 2017

Last Update Submit

January 7, 2018

Conditions

Hysterectomy

Keywords

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • pressor response attenuation

    an average of 10 minutes after induction

  • First time for analgesics requirement

    postoperative (maximum 6 hours after the end of operation)

Study Arms (2)

pregabalin group

ACTIVE COMPARATOR
Drug: Pregabalin

placebo group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PregabalinDRUG

Pregabalin capsule 150 mg oral

Also known as: laryca
pregabalin group
PlaceboDRUG

Placebo

placebo group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • American Society of Anaesthesiology (ASA) physical status ≥ III.
  • Allergy or hypersensitivity to pregabalin.
  • Patient on calcium channel blocker or anticonvulsant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Zamalek, 11586, Egypt

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 29, 2017

First Posted

October 5, 2017

Study Start

June 29, 2017

Primary Completion

September 1, 2017

Study Completion

September 20, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)