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To compare the effect of Dexmedetomidine versus midazolam, when both are given intravenously,as supplementation to Ropivacaine Spinal Anaesthesia

Comparison of intravenous Dexmedetomidine with Midazolam in prolonging spinal anaesthesia with Ropivacaine

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004535
Enrollment
60
Registered
2014-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: null- Patients undergoing lower limb and lower abdominal surgeries

Interventions

Intervention1: Ropivacaine with dexmedetomidine: Group D patients given 3 ml of Ropivacaine 0.5% (15mg) , Frequency- single shot, Route- Intrathecal
Dexmedetomidine Dose- 1mcg/kg as loading dose , followed by 0.5mcg/kg/hr , Frequency-Continuous infusion , Route- Intravenous Intervention2: Ropivacaine with Midazolam: Group M patients given 3 ml of
Midazolam Dose- 0.05mg/kg as loading dose , followed by 0.02mg/kg/hr , Frequency-Continuous infusion , Route- Intravenous Control Intervention1: Ropivacaine: Ropivacaine Dose- 3cc of 0.5%(15 mg), Sin
Normal saline given intravenously

Sponsors

Dr T S Punia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I and II Patients undergoing lower limb and lower abdominal surgery Body mass index of 30 or less Normal coagulation profile

Exclusion criteria

Exclusion criteria: Unwilling patient, history of chronic illness, spinal abnormality, local skin infection, coagulation defects, Recent MI, Allergy to the drugs being used

Design outcomes

Primary

MeasureTime frame
Time for onset of analgesia ( highest level assessed by bilateral pin prick ) Peak sensory level reached Time taken for sensory block regression by 2 dermatomes, Time taken for motor block to recede to Bromage and Postoperative Sedation produced by the two groups, Haemodynamic profile of the two groups , Need of additional analgesic , Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups Timepoint: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative

Secondary

MeasureTime frame
Time for onset of analgesia ( highest level assessed by bilateral pin prick ) Peak sensory level reached, Time taken for motor block to recede to Bromage and Postoperative Sedation produced by the two groups, Haemodynamic profile of the two groups , , Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups Timepoint: Intraoperative,Intraoperative,Postoperative, Intraoperative ,Intraoperatively every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative and Postoperative

Countries

India

Contacts

Public ContactDr Divya Arora

Government Medical College, Rajindra Hospital, Patiala

tspunia@yahoo.com9216323131

Outcome results

None listed

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