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

Hysterectomy Clinical Trial

Official title:

Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302208
• Other study ID #: UTF-9
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2017
• Last updated: January 7, 2018
• Start date: June 29, 2017
• Est. completion date: September 20, 2017

Study information

• Verified date: January 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 20, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Pregabalin
Pregabalin capsule 150 mg oral
• Placebo
Placebo

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Zamalek

Sponsors (1)

Lead Sponsor	Collaborator
Nesrine El-Refai

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pressor response attenuation	Degree of pressor response attenuation	an average of 10 minutes after induction
Secondary	First time for analgesics requirement	First time for analgesics requirement.	postoperative (maximum 6 hours after the end of operation)