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Low dose Dexmedetomidine vs Fentanyl on the recovery profile in ambulatory brachytherapy

Effect of low dose Dexmedetomidine vs Fentanyl on the recovery profile of patients undergoing ambulatory brachytherapy with Propofol TCI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037361
Enrollment
100
Registered
2021-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified Health Condition 2: C538- Malignant neoplasm of overlappingsites of cervix uteri Health Condition 3: C55- Malignant neoplasm of uterus, partunspecified Health Condition 4: O- Medical and Surgical

Interventions

Intervention1: Low dose dexmedetomidine: Will receive intravenous dexmedetomidine 0.5 mcg/kg over 5 mins prior to induction Control Intervention1: Fentanyl: Will receive intravenous fentanyl 1 mcg/kg

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I/II/III

Exclusion criteria

Exclusion criteria: 1. Any contraindication to use of supraglottic airway device 2. Advanced liver disease (liver enzymes more than 5 times the upper limit of normal) 3. History of chronic use of sedatives/ narcotics 4. Allergic to study medication

Design outcomes

Primary

MeasureTime frame
Time to awakeningTimepoint: End of surgery—

Secondary

MeasureTime frame
Time to remove airway deviceTimepoint: at the removal of I -gel;Change in hemodynamic indicesTimepoint: (blood pressure and heart rate) perioperatively;Incidence of emergence delirium using Confusion Assessment Method (CAM)Timepoint: On emergence;Duration of Post-Operative Anesthesia Care Unit (PACU) stayTimepoint: In the PACU, till Aldrete 9;Duration of hospital stayTimepoint: Till hospital discharge;Incidence of any adverse eventTimepoint: Postoperative Nausea and Vomiting, bradycardia or hypotension in the perioperative period after commencement of test or comparator drug administration;Total Propofol requirementTimepoint: Intraoperative;Estimated Ce (propofol) at i-gel insertionTimepoint: At i-gel insertion;VAS scoreTimepoint: Post-procedure VAS score at 30 minute and hourly till discharge from PACU;Rescue analgesic requirementTimepoint: Number of times rescue analgesia was needed in the PACU;time to first rescue analgesicTimepoint: In the PACU—

Countries

India

Contacts

Public ContactManisha Agrawal

PGIMER

navin.amc123@gmail.com8872377925

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026