EFFECT OF DEXMEDETOMIDINE ON ANAESTHESIA AND ANALGESIA REQUIREMENT AND RECOVERY CHARACTERISTICS DURING BISPECTRAL INDEX GUIDED ANAESTHESIA FOR NEUROSURGERY CASES

Phase 3

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/10/037597

Lead Sponsor: Dr Preeti Raj

Brief Summary: Goalsof neuroanaesthesia are to provide good operating conditions and to ensurestable cerebral haemodynamics without sudden increase in intracranial pressureor acute brain swelling.

Furthermore,rapid recovery from anaesthesia is often required to allow immediate postoperative neurological evaluation.

Anaesthesiais a balance between the amount of anaesthetic drug administered and the stateof arousal of the patient. Patient movement in response to noxious stimulationremains an important sign of inadequatedepth of anaesthesia, but is unreliableand suppressed by paralysis.Traditional clinical signs such as hypertension,tachycardia, diaphoresis and lacrimation are unreliable indicators of DOA.

Depthof anaesthesia is a simplified construct of hypnosis, amnesia, antinociceptionand reflex suppression. A widely used method to measure inhaled anaestheticrequirement is the minimum alveolar concentration (MAC) of inhaled anaestheticat which movement in response to nociceptive stimulus is suppressed in 50% ofsubjects at standard temperature and pressure.

Mostcurrent proprietary depth of anaesthesia monitors such as Bispectral Index(BIS, Aspect Medical System, Newton, NA, USA) and Spectral Entropy (GEhealthcare, Helsinki, Finland) use dimensionless monotonic index as ba measureof anaesthetic depth.

Dexmedetomidine,the pharmacologically active of isomer of medetomidine, is a highly selective and specific Î±-2adrenoceptor agonist.

Dexmedetomidine byits central sympatholytic action, promotes haemodynamic stability when used asan adjuvant during general anaesthesia. It has analgesic and anaestheticsparing property.

However,because of its sedative property, it is unknown if the recovery fromanaesthesia would be delayed when used as an continuous infusion.

TheBispectral Index(BIS) is an electroencephalogram (EEG)-derived parameter tomonitor the hypnotic effects of anaesthetics.

BISis shown to correlate well with the level of sedation produced by propofol andto accurately predict loss of consciousness.

Despitethe various limitations inherent to all brain function monitors using processedEEG signals, very recent publications have confirmed the role of the BISmonitor (Medtronic, Minneapolis,MN, USA) as one of the commercially availablestandard devices to monitor brain function for depth of anaesthesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

ASA grade I & II 2.
Ages between 18 to 60 years of either gender.
Haemodynamically stable patients with normal laboratory investigations.
Patients willing and giving consent to be a part of the study.

Exclusion Criteria

Patients not willing to be a part of the study.
Patients on pain perception modifying drugs.
Patients with known sensitivity to any of the drugs under study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EFFECT OF DEXMEDETOMIDINE ON ANAESTHESIA AND ANALGESIA REQUIREMENT AND RECOVERY CHARACTERISTICS DURING BISPECTRAL INDEX GUIDED ANAESTHESIA FOR NEUROSURGERY â€“A RANDOMISED CLINICAL TRIAL	6 months

Secondary Outcome Measures

Name	Time	Method
Depth of anaesthesia as per Bispectral index â€“guided anaesthesia.	Adverse effects if any.

Trial Locations

Locations (1): Department of anaesthesia, Dr. D Y Patil Medical College and Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Department of anaesthesia, Dr. D Y Patil Medical College and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dr Preeti Raj
Principal investigator
9810749754
hipreeti20@gmail.com