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Comparison between two drugs as an alternative to drugs causing nausea ,vomiting ,sedation and respiratory depression in spine surgeries.

Efficacy of intravenous dexmedetomidine vs lignocaine as adjuvant in opioid free anesthesia in lumbar spine surgeries :A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053997
Enrollment
50
Registered
2023-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: Intraoperative use of dexmedetomidine: Patients in group D are given 1µg/kg Dexmedetomidine over 15 min followed by 0.5µg/kg/hour Control Intervention1: Intraoperative use of lignocaine

Sponsors

St Johns Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All ASA I and II adult patients aged 18 years to 80 years posted for lumbar spine surgeries

Exclusion criteria

Exclusion criteria: 1.Pregnant and lactating women 2.Patients with intellectual disability ,dementia and alzheimer’s disease 3.Known history of hypersensitivity to local anesthetic agents 4.Coagulopathy

Design outcomes

Primary

MeasureTime frame
To assess duration of analgesia between the two groups (Lignocaine vs Dexmedetomidine) in the postoperative periodTimepoint: Duration of analgesia:Time from stop of study drug to first request of analgesia

Secondary

MeasureTime frame
To assess the hemodynamic parameters such as heart rate, Systolic blood pressure(SBP), Diastolic blood pressure(DBP) and Mean arterial pressure (MAP) and Saturation (SpO2) intraoperatively between the two groupsTimepoint: Hemodynamic parameters -HR, Blood pressure (SBP, DBP and MAP), SpO2 is monitored every 15 min until end of surgery.;To assess the total rescue analgesic (Ketamine) consumed between the two groupsTimepoint: Total rescue analgesic ( IV Ketamine) consumed at the end of surgery;To assess total analgesic consumption of lignocaine and dexmedetomidine.Timepoint: Total analgesic consumption of the study drugs.(lignocaine and dexmedetomidine);To compare side effects between the two drugs.Timepoint: Side effects like PONV, sedation, respiratory depression (Respiratory rate8) and Desaturation (SpO294%) on arrival to PACU, 20min, discharge from PACU, 2hrs,4hrs, 8hrs,12hrs and 24 hrs;To assess the total dose of rescue analgesia used postoperatively between the two groupsTimepoint: Total dose of IV PCA Fentanyl used at the end of 24 hrs;To assess NRS score at rest & movementTimepoint: PACU at 20 min, discharge from PACU 2hrs,4hrs,8hrs,12hrs & 24hrs

Countries

India

Contacts

Public ContactDr M Manjuladevi

St Johns Medical College and Hospital

remya1794@gmail.com9526034676

Outcome results

None listed

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