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Comparing two drugs as adjuvants to local anaesthetic in patients of carcinoma cervix undergoing brachytherapy procedure

A Prospective randomized double-blind study of intra-thecal low dose hyperbaric bupivacaine with dexmedetomidine or fentanyl as adjuvants for brachytherapy( Day Care Procedure) in carcinoma of the cervix.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042677
Enrollment
70
Registered
2022-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-30

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

Interventions

Intervention1: Group I- Dexmedetomidine: Dexmedetomidine - 3 micrograms Bupivacaine- 1.8 ml Route - Intra-thecal Single dose Control Intervention1: Group II- Fentanyl: Fentanyl - 15 micrograms Bupiva

Sponsors

Homi Bhabha Cancer Hospital Research Centre Punjab
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients of carcinoma cervix posted for intracavitary brachytherapy 2)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Refused consent for spinal anaesthesia 2)Patients who need admission overnight 3)Any contraindications to spinal anaesthesia (including coagulopathy, low absolute neutrophil count, allergic to local anaesthetic) 4)Patients with raised intracranial pressure, peripheral neuropathy, demyelinating central nervous system disorders, local sepsis were excluded

Design outcomes

Primary

MeasureTime frame
Comparing the absolute duration of spinal analgesia among the two groups.Timepoint: Over 12 hours post-spinal anaesthesia.—

Secondary

MeasureTime frame
1. VAS Pain Scores 2. Quality of spinal anaesthesia 3. Sedation Score 4. Time to achieve hospital discharge criteria 5. Patient Satisfaction ScoreTimepoint: 1.5-15 minutes during procedure after that every 30 minutes 2. At the end of procedure 3. 5-15 minutes during procedure after that every 30 minutes 4. Every 30 minutes post procedure 5. After 12 hrs post spinal anaesthesia.—

Countries

India

Contacts

Public ContactJagdeep Sharma

Homi Bhabha Cancer Hospital & Research Centre PUNJAB

snehlatas222@gmail.com016272-223910

Outcome results

None listed

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