Condition category
Surgery
Date applied
09/03/2017
Date assigned
20/03/2017
Last edited
20/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A modified radical mastectomy is a procedure in which the entire breast is removed in order to remove breast cancer. A flexible plastic tube is placed into the trachea (windpipe) to keep the airway open (tracheal intubation). The aim of this study is to find out whether the drugs midazolam and gabapentin can reduce the stress response (increased heart rate and blood pressure) to tracheal intubation.

Who can participate?
Patients aged between 18 and 65 undergoing modified radical mastectomy

What does the study involve?
Participants are randomly allocated into two groups. One group is given oral gabapentin and midazolam 90 minutes before intubation. The other group is given gabapentin 90 minutes before intubation. Heart rate, blood pressure, sedation and side effects are measured to see whether gabapentin and midazolam can reduce the stress response to tracheal intubation.

What are the possible benefits and risks of participating?
The results of this study will increase scientific knowledge and may benefit future patients.

Where is the study run from?
National Cancer Institute, Cairo University (Egypt)

When is the study starting and how long is it expected to run for?
February to June 2017

Who is funding the study?
National Cancer Institute, Cairo University (Egypt)

Who is the main contact?
Dr Ahmed Bakir
ahmed_bakir77@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ahmed Bakir

ORCID ID

Contact details

National Cancer Institute
Cairo University
cairo
-
Egypt
+20 (0)111 566 1922
ahmed_bakir77@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

201617009.2p

Study information

Scientific title

Attenuation of haemodynamic response to tracheal intubation with oral gabapentin and midazolam in breast cancer patients: a randomised controlled trial

Acronym

Study hypothesis

Does preoperative oral gabapentin and midazolam attenuate the stress response of tracheal intubation in breast cancer patients?

Ethics approval

Ethics committee of National Cancer Institute, Cairo University, 01/03/2017, ref: 201617009.2p

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Modified radical mastectomy under general anaesthesia

Intervention

Patients are randomised into two groups:
1. Oral gabapentin 800 mg plus 7.5 mg midazolam
2. Oral gabapentin 800 mg
Both drugs are given 90 min prior to surgery and patients are followed up to 24 hours postoperatively

Intervention type

Phase

Drug names

Primary outcome measures

1. Heart rate measured by electrocardiogram and pulse oximetry
2. Blood pressure measured by non invasive blood pressure monitor
Measured at baseline and at 0, 1, 3, 5, 10, 15 and 30 minutes of intubation

Secondary outcome measures

1. Sedation measured using Ramsay Sedation Scale
2. Side effects (e.g. nausea or vomiting) recorded by physician staff
Recorded over 24 h postoperatively

Overall trial start date

15/02/2017

Overall trial end date

08/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. ASA1 or 2 patients
2. Between 18 to 65 years of age
3. Undergoing modified radical mastectomy under general anaesthesia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60 patients in the two groups

Participant exclusion criteria

1. Allergy to gabapentin or midazolam
2. Severe renal or liver insufficiency
3. Patient refusal

Recruitment start date

15/02/2017

Recruitment end date

15/05/2017

Locations

Countries of recruitment

Egypt

Trial participating centre

National Cancer Institute, Cairo University
-

Sponsor information

Organisation

National Cancer Institute, Cairo University

Sponsor details

Fom Elkhalig Street
cairo
0000
Egypt
+20 (0)111 566 1922
ahmed_bakir77@yahoo.com

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

National Cancer Institute, Cairo University

Alternative name(s)

NCI

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Egypt

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ahmed Bakir (ahmed_bakir77@yahoo.com)

Intention to publish date

08/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes