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Comparative evaluation of isobaric ropivacaine (0.75%) with the adjuvants - clonidine and dexmedetomidine administered intrathecally in adult patients undergoing infra-umbilical surgeries

Comparative evaluation of isobaric ropivacaine (0.75%) with the adjuvants - clonidine and dexmedetomidine administered intrathecally in adult patients undergoing infra-umbilical surgeries

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000581864
Enrollment
90
Registered
2012-05-30
Start date
2012-04-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

In this randomized double blind prospective clinical study we plan to evaluate the efficacy of adding Clonidine (30mcg), Dexmedetomidine (5mcg) or isotonic saline to 0.75% isobaric Ropivacaine for administration of subarachnoid lumbar block in infra-umbilical surgical procedures with regard to characteristics of sensory and motor block and observation of any side effects.

Interventions

In this randomized double blind prospective clinical study we plan to evaluate the efficacy of adding Clonidine (30mcg), Dexmedetomidine (5mcg) or isotonic saline to 0.75% isobaric Ropivacaine for administration of subarachnoid lumbar block in infra-umbilical surgical procedures with regard to characteristics of sensory and motor block and observation of any side effects. Each of these treatments will be given on just one occasion Thereare three groups. GROUP RS (Ropivacaine + Isotonic Saline

In this randomized double blind prospective clinical study we plan to evaluate the efficacy of adding Clonidine (30mcg), Dexmedetomidine (5mcg) or isotonic saline to 0.75% isobaric Ropivacaine for administration of subarachnoid lumbar block in infra-umbilical surgical procedures with regard to characteristics of sensory and motor block and observation of any side effects. Each of these treatments will be given on just one occasion Thereare three groups. GROUP RS (Ropivacaine + Isotonic Saline) is the control group They will be administered 3.0ml of 0.75% isobaric Ropivacaine + 0.2ml of Isotonic Saline (total volume of injectate 3.2ml) GROUP RC (Ropivacaine + Clonidine) They will be administered 3.0ml of 0.75% isobaric Ropivacaine + 30mcg of Clonidine (0.2ml Inj. Clonidine; total volume of injectate 3.2ml) GROUP RD (Ropivacaine + Dexmedetomidine) They will be administered 3.0ml of 0.75% isobaric Ropivacaine + 5mcg of Dexmedetomidine (0.05ml of Dexmedetomidine diluted to 0.2ml in isotonic saline; total volume of injectate 3.2ml)

Sponsors

safdarjung hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients scheduled to undergo elective infra-umbilical surgery ASA grades 1 and 2 height : 150 to 180 cms Duration of surgery not exceeding 2 1/2 hours

Exclusion criteria

Patient refusal ASA grades 3 and 4 Contraindications to spinal anaesthesia (absolute and relative) Patients with the following cardiovascular disorders: Heart rate < 55 beats/min Patients on antihypertensive drug therapy Those on heparin therapy, aspirin and other anti-platelet drug therapy Hepatic and renal disorders Obesity pregnancy Psychosis, dementia and other co-operation disorders Peripheral neuropathy Demyelinating central nervous system disorders Disorders of spine eg. scoliosis Chronic analgesic usage Known hypersensitivity to drugs

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026