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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ISRCTN15943548 |
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Date of registration:
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20/03/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Attenuation of haemodynamic response to tracheal intubation with oral gabapentin and midazolam in breast cancer patients
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Scientific title:
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Attenuation of haemodynamic response to tracheal intubation with oral gabapentin and midazolam in breast cancer patients: a randomised controlled trial |
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Date of first enrolment:
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15/02/2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN15943548 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Prevention)
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Phase:
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ahmed
Bakir |
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Address:
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National Cancer Institute
Cairo University
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cairo
Egypt |
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Telephone:
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+20 (0)111 566 1922 |
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Email:
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ahmed_bakir77@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. ASA1 or 2 patients
2. Between 18 to 65 years of age
3. Undergoing modified radical mastectomy under general anaesthesia
Exclusion criteria: 1. Allergy to gabapentin or midazolam
2. Severe renal or liver insufficiency
3. Patient refusal
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Modified radical mastectomy under general anaesthesia
Surgery
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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1. Sedation measured using Ramsay Sedation Scale
2. Side effects (e.g. nausea or vomiting) recorded by physician staff
Recorded over 24 h postoperatively
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Secondary ID(s)
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201617009.2p
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Source(s) of Monetary Support
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National Cancer Institute, Cairo University
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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