A study to compare two drugs (dexmedetomidine and nitroglcerine) used to decrease blood pressure during operation in a controlled manner while using a technology (near infrared spectroscopy) to measure oxygen saturation in brain

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue,

• Registration Number: CTRI/2018/10/016206
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Controlledhypotension is frequently used during anaesthesia to target a mean arterialpressures between 55-65 mm Hg to decrease blood loss during surgeries andimprove the visualisation of operative field. Many techniques have been usedand compared in literature but with outcomes like amount of blood loss,surgeon’s satisfaction and recovery profiles. Near infrared spectroscopy (NIRS)has established role in measuring regional tissue oxygen saturation especiallyin the cerebral oxygen saturation (rScO2). It’s application has been limited inevaluating the effect of various drugs used for controlled hypotension duringanaesthesia. This study will compare the effects of dexmedetomidine andnitroglycerin, two of the commonly used drugs for controlled hypotensiveanaesthesia on rScO2, cerebral desaturation events and the interventionsrequired.

The two groups werecomparable in terms of demographic profile, baseline haemodynamics and regionalcerebral oxygen saturation. The difference in the heart rates in the two groupswas statistically significant (p- value < 0.05) and considering a 95% confidenceinterval, it was more favourable towards Group D. The two groups werecomparable in terms of mean arterial pressure and rScO2 at allthe time points. There was no difference in the occurrence of CDE in thetwo groups. POCD could not be assessed in the patients on the thirdpostoperative day since they were being discharges before that. Hence, MMSEscores were not captured in any of the patients.

**To conclude,**Dexmedetomidine is non inferior to nitroglycerinwhen used for controlled hypotensive anaesthesia (target MAP 55-65 mm of Hg) insurgeries of head and neck with head in neutral position and lasting less thantwo hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-11
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status I and II and scheduled to undergo surgery in supine position with neutral head position, under general anaesthesia with controlled hypotension will be enrolled for this randomised non-inferiority trial.

Exclusion Criteria

Preexisting cerebral pathology, Cognitive disability, Carotid artery stenosis, Cardiac disease, Orthostatic hypotension, Sensitivity to study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the occurrence of cerebral desaturation events caused by use of dexmedetomidine and nitroglycerin for controlled hypotensive anaesthesia.	30 minutes

Secondary Outcome Measures

Name	Time	Method
To compare the effects of dexmedetomidine and nitroglycerin on	left and right regional cerebral oxygen saturation, haemodynamics (blood pressure and

Trial Locations

Locations (1)

AIIMS JODHPUR; 🇮🇳 Jodhpur, RAJASTHAN, India

AIIMS JODHPUR

🇮🇳Jodhpur, RAJASTHAN, India

Dr Swati Chhabra

Principal investigator

7340033034

swati_virgo83@yahoo.co.in