Comparing different methods of monitoring pain, heart rate and blood pressure with opioid and non opioid medicines in patients undergoing the brain surgeries.

Completed

Conditions: Benign neoplasm of brain, supratentorial,

Registration Number: CTRI/2023/02/050005

Lead Sponsor: NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES

Brief Summary: We hypothesize that while the performance of SPI(Surgical Pleth Index) may be similar with opioid and OFA (Opioid Free Analgesia), ANI(Analgesia Nociceptive Index) changes with noxious stimuli during surgery may be different (smaller magnitude of change with stimuli) due to the effect of dexmedetomidine on Heart Rate Variation.

Dexmedetomidine has been shown to cause an increase in the HF (high frequency) component of power in ANI spectra. (Increase in HF component power indicates predominant parasympathetic surge).

SPI has been effectively used as a guide to analgesia in patients receiving opioid and non opioid analgesia undergoing supratentorial craniotomies.10 Studies have established that ANI can detect painful stimuli in patients undergoing general surgeries under anaesthesia with opioid free analgesia.

To the best our knowledge there are no studies assessing the performance of ANI in detecting nociception in patients receiving OFA in neurosurgical population.

Hence, we intend to compare the changes in ANI, SPI and the hemodynamic parameters to nociception in patients receiving opioid and non opioid analgesia undergoing supratentorial craniotomies.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 58

Inclusion Criteria

Patients aged between 18 and 65years of ASA I and II -Patients undergoing elective supratentorial craniotomy.

Exclusion Criteria

Patients in whom dexmedetomidine is contraindicated (second and third degree heart block), -Patients in whom ANI will be unreliable (patients with pacemakers, patients on drugs affecting sinus node, patients having arrhythmias).
Patients with liver and renal diseases.
Patients on gabapentinoids, tricyclic antidepressants and other analgesics -Patients posted for aneurysmal clipping -Patients with decreased sensorium.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the magnitude of change and response time in ANI, SPI and hemodynamic parameters (HR and MAP) to various noxious stimuli between patients receiving OFA with dexmedetomidine and those receiving opioid analgesia with fentanyl for	Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.
supratentorial craniotomies.	Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.
(Response time is the time taken for the parameter to change maximally due to noxious	Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.
BP)	Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.
(Magnitude of change is the difference between highest/lowest value after stimulation as compared to baseline i.e. pre-stimuli value)	Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.
stimuli from the pre-stimuli value, i.e. lowest for the ANI and highest for SPI, HR and	Before starting analgesic drug infusion and after 5 min and 10 min of starting infusion. At Intubation, skull pin insertion, skin incision, first burr hole placement, and durotomy.

Secondary Outcome Measures

Name	Time	Method
-To compare the magnitude of change and response timein ANI, SPI, hemodynamics with in the group	-To determine and correlation between ANI and SPI in patients receiving opioid and OFA

Trial Locations

Locations (1): NATIONAL INSTITUTE MENTAL HEALTH AND NEUROSCIENCES
🇮🇳
Bangalore, KARNATAKA, India
NATIONAL INSTITUTE MENTAL HEALTH AND NEUROSCIENCES
🇮🇳Bangalore, KARNATAKA, India
RAKESH T L
Principal investigator
9535751263
rakeshtambi92@gmail.com