Comparison of dexmedetomidine and clonidine with 0.5% hyperbaric levobupivacaine in spinal anaesthesia

A comparative study of dexmedetomidine versus clonidine as adjuvant to intrathecal 0.5 percent hyperbaric levobupivacaine in infraumbilical surgeries - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080377

Enrollment

100

Registered

2025-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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 Health Condition 2: 4- Measurement and Monitoring

Interventions

Control Intervention1: 30 mcg (0.2ml) of clonidine as adjuvant to intrathecal 3ml (15mg) of 0.5% hyperbaric levobupivacaine: to determine and compare the effects, safety and efficacy of 30mcg clonidi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of American society of Anaesthesiologists physical status I and II 2. Age 18yrs to 80 yrs 3. Patients undergoing Infraumbilical Surgeries 4. Patients who have given informed written consent

Exclusion criteria

Exclusion criteria: 1. Patient refusal. 2. Patients of American society of Anaesthesiologists physical status III and IV. 3. Coagulopathies. 4. Infection at site of lumbar puncture. 5. Allergy to local anaesthetic drugs, dexmedetomidine & clonidine. 6. H/o seizures/ neurological deficit. 7. Lack of informed written consent.

Design outcomes

Primary

Measure	Time frame
1.To determine the time to onset and duration of sensory and motor block 2.To determine the quality of intraoperative anaesthesia Timepoint: 1.Time to onset of sensory, motor block, from spinal injection-at level of umbilicus-assessed at baseline,1min,3min,5min,7min,10min,15min. Duration of sensory and motor blockade- assessed at baseline, 30min,60min,90min,every 30min during and after surgery. 2. quality of intraoperative anaesthesia-assessed at baseline,1min,3min,5min,10min and 10min thereafter until end of surgery.	—

Measure

Time frame

1.To determine the time to onset and duration of sensory and motor block 2.To determine the quality of intraoperative anaesthesia Timepoint: 1.Time to onset of sensory, motor block, from spinal injection-at level of umbilicus-assessed at baseline,1min,3min,5min,7min,10min,15min. Duration of sensory and motor blockade- assessed at baseline, 30min,60min,90min,every 30min during and after surgery. 2. quality of intraoperative anaesthesia-assessed at baseline,1min,3min,5min,10min and 10min thereafter until end of surgery.

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Secondary

Measure	Time frame
1.To determine the time taken for first rescue analgesia 2.To determine adverse effects Timepoint: 1.time taken for first rescue analgesia-assessed postoperatively at 15min,30min,45min,60min & every 30min thereafter 2.Patient is monitored for adverse effects(headache, nausea, confusion, hypotension, bradycardia, etc), hemodynamic parameters at baseline,1min,3min,5min,15min,30min,45min,1hr & every 30 min postoperatively & will be managed meticulously	—

Measure

Time frame

1.To determine the time taken for first rescue analgesia 2.To determine adverse effects Timepoint: 1.time taken for first rescue analgesia-assessed postoperatively at 15min,30min,45min,60min & every 30min thereafter 2.Patient is monitored for adverse effects(headache, nausea, confusion, hypotension, bradycardia, etc), hemodynamic parameters at baseline,1min,3min,5min,15min,30min,45min,1hr & every 30 min postoperatively & will be managed meticulously

—

Countries

India

Contacts

Public ContactDr S Selvamani

ACS Medical College and Hospital

dr.selvamani1957@gmail.com9444357942

Outcome results

None listed

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