Preoperative Oral Pregabalin Effect on Inhalational Anest... | NCT03302208

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

NCT03302208

Sponsor

Nesrine El-Refai

Status

Completed

Last Update Posted

Jan 9, 2018Actual

Enrollment

50Actual

Phase

Phase 3

Conditions

Hysterectomy

Interventions

Pregabalin
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2017Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Sep 20, 2017Actual

First Submitted Date

Jun 29, 2017

First Submission Date that Met QC Criteria

Oct 3, 2017

First Posted Date

Oct 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2018

Last Update Posted Date

Jan 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pregabalin group	Active Comparator		Drug: Pregabalin
placebo group	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	Pregabalin capsule 150 mg oral	pregabalin group	laryca

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo	Zamalek	11586	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 31, 2017	Oct 5, 2017	Prot_SAP_002.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

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