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Attenuation of haemodynamic response to tracheal intubation with oral gabapentin and midazolam in breast cancer patients

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15943548
Enrollment
60
Registered
2017-03-20
Start date
2017-02-15
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Modified radical mastectomy under general anaesthesia Surgery

Interventions

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 hour

Sponsors

National Cancer Institute, Cairo University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Egypt

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026