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A study of the effect of fentanyl boluses versus infusion on surgical plethysmographic index during surgery

Randomised controlled trial to compare the effect of fentanyl given as boluses or infusion intraoperative on surgical plethysmographic index

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029056
Enrollment
50
Registered
2020-11-11
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: H600- Abscess of external ear Health Condition 2: K110- Atrophy of salivary gland Health Condition 3: H720- Central perforation of tympanic membrane Health Condition 4: H662- Chronic atticoantral suppurative otitis media Health Condition 5: H652- Chronic serous otitis media Health Condition 6: H661- Chronic tubotympanic suppurative otitis media Health Condition 7: N601- Diffuse cystic mastopathy Health Condition 8: N602- Fibroadenosis of breast Health Condition 9: N603- Fibro

Interventions

Intervention1: Bolus group: Intravenous Fentanyl 1 microgram/kg every hour from the beginning of surgery till 15 minutes prior to extubation Control Intervention1: Infusion group: Intravenous Fentanyl

Sponsors

Kasturba Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients undergoing an elective procedure requiring general anaesthesia -American society of anesthesiology physical status 1 and 2 patients -BMI 18.5 to 34.9 Kg/m2

Exclusion criteria

Exclusion criteria: -Patients who are diagnosed with any form of arrhythmia -Patients on pacemaker -Patients with compromised kidney function -Patients posted in an operating theatre not equipped with SPI monitor

Design outcomes

Primary

MeasureTime frame
Efficacy of bolus versus infusion of fentanyl to maintain intraoperative SPI value less than 40Timepoint: Before induction of anesthesia After induction of anesthesia After intubation done After incision made by surgeon Every 5 minutes throughout procedure

Secondary

MeasureTime frame
Post-operative analgesia can be assessed with help of Numerical rating scaleTimepoint: 15 minutes after extubation pain will be assessed on scale of 1 to 10

Countries

India

Contacts

Public ContactDr Krishna H M

Kasturba Medical College,Manipal

hmkrishna20032002@yahoo.com07718842645

Outcome results

None listed

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