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Anesthesia for elderly patients undergoing brain tumor surgery without opioids.

OPIoid sparing Anesthesia Technique for supratentorial craniotomy in geriatric patients [OPIATE]: a randomized open labelled study - OPIATE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028784
Enrollment
22
Registered
2020-11-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Dexmedetomidine and scalp block: Dexmedetomidine bolus @1mcg/kg over 10 mins before induction followed by 0.2-0.7 mcg/kg/hr. + Scalp block with ropivacaine [0.25%] after induction of an

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. American Society of Anesthesiologists class I&II 3. Age of >65 years 4. Either gender 5. Supratentorial brain tumor with tumor diameter of 6. Full Glasgow coma score (E4V5M6) 7. Estimated operative time of

Exclusion criteria

Exclusion criteria: 1. Non consenting patient 2. Any history of previous brain surgery 3. Current or past history of any cardiac disease or medication 4. Any history of lung disease, liver or kidney dysfunction 5. Patients who had sensitivity to opioids, dexmedetomidine, ropivacaine 6. Body mass index of > 35 kg/m2 7. Preoperative cognitive dysfunction

Design outcomes

Primary

MeasureTime frame
1.Time to emergence 2.Postoperative immediate painTimepoint: 1.From discontinuation of anesthetics to eye opening on command in minutes 2. 10 minutes after extubation

Secondary

MeasureTime frame
1. Extubation timeTimepoint: 1. From discontinuation of anesthetics to tracheal extubation in minutes;10. Intraoperative hemodynamic disturbances [hypotension, bradycardia] Timepoint: intraoperative period;11. Intraoperative fentanyl consumption Timepoint: End of surgery;2. Postoperative deliriumTimepoint: 2. Assessed using CAM-ICU 60 minutes after extubation;3. Postoperative early cognitive dysfunctionTimepoint: Assessed using MMSE 60 minutes after extubation];4. Postoperative side effects: nausea,vomiting, shivering, hemodynamic instability, respiratory depressionTimepoint: Postoperative period[24 hrs];5. Other respiratory parameters (any subclinical respiratory depression): Ph, PaO2, PaCo2, Hco3, Lact, Sao2, HbTimepoint: Postoperative period [24 hrs];6. Time for first rescue analgesic:Timepoint: Postoperative period [24 hrs];7. Length of ICU stay Timepoint: .;8. Length of Hospital stay Timepoint: .;9. Intraoperative brain relaxation [Cerebral relaxation score] Timepoint: intraoperative period

Countries

India

Contacts

Public ContactIndu Kapoor

AIIMS, NEW DELHI

dr.indu.me@gmail.com09013439134

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026