Evaluating the Effect of Epidural Clonidine as an Adjuvant to 0.5% Bupivacaine intrathecally in Combined Spinal Epidural Anaesthesia in lower limb orthopedic surgery.

A randomized controlled double blind study of the effect of Epidural Clonidine as an Adjuvant to 0.5% Intrathecal Bupivacaine in combined spinal Epidural in Lower Limb Orthopedic Surgeries at SMS Medical College Jaipur during 2021-2023

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042029

Enrollment

Registered

2022-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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: injection clonidine: injection Clonidine 75mcg diluted to 5ml in normal saline via epidural needle 10 min prior to spinal anaesthesia in combined spinal epidural Control Intervention1:

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting for lower limb Orthopedic Surgery,Patient with ASA 1&2, scheduled for Elective Orthopedic Surgery

Exclusion criteria

Exclusion criteria: Patient Refusal, Patients with Significant Cardiovascular Disease,renal failure,hepatic dysfunction, chronic pulmonary disease and Diabetes mellitus,Neuromuscular disorder, Infection, Bleeding Disorder, Obesity( BMI >30kg/m2), History of Allergy or sensitivity to any of the study drug in previous surgery, Psychiatric illness, Antihypertensive therapy

Design outcomes

Primary

Measure	Time frame
Mean Time of onset of Sensory Block at T10 dermatomesTimepoint: after 30 sec till 10 min	—

Secondary

Measure	Time frame
Mean HR, SBP, DBPTimepoint: baseline, before CSE, just after CSE , 5min after CSE , 10 min, 15 min, 20 min then every 10 min till 90 min;Mean RAMSAY Sedation ScoreTimepoint: after 30 min of surgery, after 60 min, after 2hr of surgery then every 1hr till 6hr of surgery;Mean time of duration of motor blockTimepoint: intraoperative period and postoperative period;Mean time of onset of motor blockTimepoint: intaoperative period;Mean time of two segment regressionTimepoint: intraoperative period;Mean total duration of analgesiaTimepoint: intraoperative and postoperative period;Mean VAS ScoreTimepoint: after 30 min of surgery , after 60 min of surgery, after 2 hrs then every 1hr till 6hrs;Proportion of cases with side effectTimepoint: if any	—

Measure

Time frame

Mean HR, SBP, DBPTimepoint: baseline, before CSE, just after CSE , 5min after CSE , 10 min, 15 min, 20 min then every 10 min till 90 min;Mean RAMSAY Sedation ScoreTimepoint: after 30 min of surgery, after 60 min, after 2hr of surgery then every 1hr till 6hr of surgery;Mean time of duration of motor blockTimepoint: intraoperative period and postoperative period;Mean time of onset of motor blockTimepoint: intaoperative period;Mean time of two segment regressionTimepoint: intraoperative period;Mean total duration of analgesiaTimepoint: intraoperative and postoperative period;Mean VAS ScoreTimepoint: after 30 min of surgery , after 60 min of surgery, after 2 hrs then every 1hr till 6hrs;Proportion of cases with side effectTimepoint: if any

—

Countries

India

Contacts

Public ContactDr T Mirthun Thomas

Sawai Man Singh Medical College and Attached Hospitals

drsonalisms@gmail.com9214540552

Outcome results

None listed

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