Opioid versus alternative drug for pain management during brain surgery

Phase 4

Recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/09/045705

Lead Sponsor: Sriganesh Kamath

Brief Summary: Opioids are associated with unwanted adverse effects. Prolonged, overuse of opioid is a major public health problem across the world. In the healthcare setting, maximal opioid usage occurs during surgery and pain management. To overcome opioid-associated complications, alternatives to opioids are explored. Dexmedetomidine when added to opioid reduces the adverse effects and anesthetic and opioid consumption in neurosurgical patients. Our pilot study showed non-inferiority of dexmedetomidine (as primary non-opioid analgesic) to fentanyl (opioid analgesic) for perioperative pain management in neurosurgery. Hence, we intend to conduct this larger trial to confirm our preliminary findings. This will provide an effective and safe alternative to opioids for perioperative pain management.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 500

Inclusion Criteria

All consecutive consenting adult patients undergoing elective craniotomies for supratentorial brain tumors with Glasgow Coma Scale score of 15 will be included in this trial.

Exclusion Criteria

We will exclude patients from this trial if they do not consent or if they have a current or past history of ischemic heart disease, cardiac failure (New York Heart Association grade â‰¥ 3), heart block or arrhythmia, untreated hypertension and diabetes mellitus, emergency surgery, pre-existing pain and receiving regular long-term drugs to manage pain, history of vomiting, previous cranial surgery, allergy to study drugs and opioid dependence as per the Diagnostic and Statistical Manual of mental disorders IV criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Rescue fentanyl consumption during surgery	1.During surgery \| 2.After surgery
2.Postoperative pain using Numerical Rating Scale score	1.During surgery \| 2.After surgery

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	24 hours after surgery
Persistent pain and quality of life	At 3 and 6 months after surgery
Adverse events	During and upto 60 minutes after surgery
Quality of sleep	1st postoperative day
Quality of recovery from anesthesia and emergence delirium	End of anesthesia till 60 minutes after surgery

Trial Locations

Locations (5): Christian Medical College, Vellore
🇮🇳
Vellore, TAMIL NADU, India
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)
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Pondicherry, PONDICHERRY, India
National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru
🇮🇳
Bangalore, KARNATAKA, India
Nizams Institute of Medical Sciences (NIMS), Hyderabad
🇮🇳
Hyderabad, TELANGANA, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum
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Thiruvananthapuram, KERALA, India
Christian Medical College, Vellore
🇮🇳Vellore, TAMIL NADU, India
Dr Georgene Singh
Principal investigator
9443292504
georgenesingh@gmail.com