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Dose finding study for cervical cancer patients under going surgery in spinal anaesthesia

Calculating 95% effective dose (ED 95) of hyperbaric bupiva-caine for intracavitary radiotherapy under sub-arachnoid block in patients with carcinoma cervix: A sequential allocation study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042241
Enrollment
40
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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: Hyperbaric bupivacaine, 5mg/cc.: Route - intrathecal (spinal), Frequency - single dose before the surgical procedure at the time of spinal anaesthesia, dose - ranging of hyperbaric bup

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status - 1 and 2 The first session of ICRT Consenting to participate in the study

Exclusion criteria

Exclusion criteria: The second or third session of ICRT Allergic to local anaesthetetics Any contraindication to spinal anaesthesia

Design outcomes

Primary

MeasureTime frame
â?¢Effective dose of hyperbaric bupivacaine in 95% of cases (ED 95) giving both adequate sensory level and optimal patient satisfaction. Adequate sensory level defined as a level of T10 or above.Timepoint: Assessment for sensory loss to be done every 5 minutes in the operation theatre after giving spinal till a highest level is recorded.

Secondary

MeasureTime frame
1. Post operatively the time taken for motor recovery. (Assessed with Bromage scale every 10 minutes in the post anaesthesia care room â?? PACU; motor recovery defined as a Bro-mage score of 3 or more)Timepoint: Every 10 minutes in post anaesthesia care unit;2. Time for sensory block regression till S1 dermatome. (Cold sensation test, every 10 minutes done in PACU)Timepoint: Every 10 minutes in post anaesthesia care unit;3. Time to shift out from PACU (defined as Bromage score of 3 or more)Timepoint: Recovery room post anaesthesia;4. The time of discharge from the hospital (Defined as ability to walk unaided and ability to void)Timepoint: Post op day 0;5. Surgeon satisfaction scoreTimepoint: Post op

Countries

India

Contacts

Public ContactSaurabh Vig

AIIMS

saurabh377@yahoo.com09538247725

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026