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Study to comparison of Intravenous Lidocaine and dexmedetomidine Infusions on quality of recovery In ENT surgeries. A Randomized, Double-Blinded, Controlled trial

Comparison of Intravenous Lidocaine and dexmedetomidine Infusions on quality of recovery (QoR-15) and quality of surgical field in functional endoscopic sinus surgery (FESS): A Randomized, Double-Blinded, Controlled trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065997
Enrollment
96
Registered
2024-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: J329- Chronic sinusitis, unspecified

Interventions

Intervention1: Group 2 (L): dose- Loading dose of IV lidocaine 1.5 mg/kg slowly just before induction of anesthesia, then the lidocaine infusion started at a rate of 1.5 mg/kg/h. route of administrati

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 - 60 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective functional endoscopic sinus surgery under general anaesthesia.

Exclusion criteria

Exclusion criteria: Patient’s refusal, Allergies to local anesthetic drugs Significant cardiovascular disease, hepatic dysfunction or renal dysfunction, Known coagulation defects, Inability to communicate, Chronic opioid usage, Poorly controlled hypertension, Use of B- Blockers, History of Bradycardia episodes /Atrio-ventricular block / Conduction defects.

Design outcomes

Primary

MeasureTime frame
Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusionTimepoint: Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusion

Secondary

MeasureTime frame
Mean /median quality of surgical field score (for the severity of bleeding and the need for frequent suctioning) among study groups Mean total analgesic consumption in the first 24 postoperative hours (Intra-operative + post- operative analgesic consumption) among study groups Mean changes in hemodynamic parameters such as Heart rate (HR) and Blood pressure (Systolic, Diastolic, Mean) among study groups Percentage of patients experiencing adverse events or complications if any.Timepoint: 24 hours

Countries

India

Contacts

Public ContactDr Priyanka Dwivedi

AIIMS GKP

drpriyad1111@gmail.com8795453444

Outcome results

None listed

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