To study the effects of sedative drug- dexmedetomidine- during general anaesthesia for endoscopic pituitary surgery.
- Conditions
- Scheduled for trans-sphenoidal pituitary surgery
- Registration Number
- CTRI/2018/03/012630
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
A prospective randomized double blind study wasconducted in 40 ASA I-II patients between 18-65 years of both sexes, undergoingelective trans-sphenoidal surgery for pituitary tumors. In this study wecompared the effect of dexmedetomidine and placebo on intra operativehemodynamics of patients including SBP, DBP, MAP, HR, as well as effectson intraoperative bleeding, requirement of intraoperative analgesia/anaesthesia and recovery profile.
The changes in heartrate were not significantly different from the baseline in Group D throughoutthe procedure and there was significant increase in HR in Group P afterextubation (p<0.05). MAP decreased significantly from baseline at 5minutes after local infiltration and at 30, 40, 50, 60 and 70 minutes afterstart of surgery in group D (p<0.05). In group P, though the MAP decreased,the magnitude of decrease was not significant from thebaseline. On comparing the two groups, increase in HR inresponse to intubation was significantly blunted in Group D. HR wasconsistently lower and controlled in Group D during surgery though thedifference was not statistically significant. The absolute values of MAP werelower and in the clinically desirable range of 75-85 mm Hg in GroupD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
40 ASA I-II patients between 18-65 years of age, scheduled for elective trans-sphenoidal pituitary surgery.
Patients with following conditions: 1.Decreased level of consciousness 2.Increased intracranial pressure 3.Risk of impending cerebral herniation 4.Anticipated elective postop ventilation 5.Co-existing intracranial lesions like aneurysms or arteriovenous malformations 6.Significant cardiovascular co-morbidity like unstable angina, recent myocardial infarction, coronary artery bypass surgery, refractory arrhythmias, severe hypertension, congestive heart failure, 7.Those with severe respiratory disease such as bronchial asthma 8.Those with body weight more than 130% of ideal body weight.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Haemodynamic changes in mean arterial blood pressure and heart rate During procedure-every 10 minutes
- Secondary Outcome Measures
Name Time Method Bleeding in surgical field During procedure Isoflurane requirement During procedure Recovery parameters Immediate postop
Trial Locations
- Locations (1)
PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaPreethy J MathewPrincipal investigator7087009530tjpreethy@gmail.com