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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list