Using Lidocaine or Dexmedetomidine to Help Control Blood Pressure Spikes From a Tourniquet During Knee Surgery

NCT06936410 | Completed Phase 2

• 1 other identifier: Ms-532-2023
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Knee pain is very common, and more people are having minor knee surgeries done through a small camera (arthroscopy), often as outpatients. During these surgeries, a device called a tourniquet is used to reduce bleeding by stopping blood flow to the leg. However, this can sometimes cause a sharp rise in blood pressure-a condition known as tourniquet-induced hypertension (TIH), which happens in about 67% of patients under general anesthesia. this study looked at two different drugs-Dexmedetomidine and Lidocaine- to see which one works better in preventing this blood pressure rise during surgery. Dexmedetomidine is a medicine that calms the nervous system and helps lower blood pressure and pain, but it can sometimes cause side effects like a slow heart rate and low blood pressure. Lidocaine, commonly used to numb pain, also helps with inflammation and controlling pain sensitivity. In this study, both drugs helped reduce TIH, but Dexmedetomidine was more effective. However, it came with more side effects compared to Lidocaine.

Conditions

Tourniquet Hypertension

Keywords

lidocaine; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Incidence of tourniquet induced hypertension

  which is defined as increase in the SBP 30% from the baseline reading in both groups, at 60 mins after tourniquet inflation

  from 60 minutes after tourniquet inflation till end of surgery

Secondary Outcomes (1)

• Hemodynamic measurements: SBP, DBP, MAP and HR.

  from baseline till 1 hour after end of operation

Study Arms (2)

lidocaine group (group L)

ACTIVE COMPARATOR

patients received Lidocaine 2%, 1 mg/kg, IV bolus over 10 mins after the induction of anaesthesia , followed by Lidocaine infusion (2 mg/kg/h) diluted in 50 ml of normal saline with a maximum dose of 200 mg/h. The tourniquet was inflated 10 minutes after the start of the Lidocaine infusion then the Lidocaine infusion stopped at the time of tourniquet deflation

Drug: Dexmedetomidine HCL Injection

dexmedetomidine group (group D)

ACTIVE COMPARATOR

atients received a loading dose of Dexmedetomidine-Pfizer (0.8 μg·kg-1 over 10 min) followed by continuous infusion of Dexmedetomidine (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline. The tourniquet was inflated 10 mins after the start of Dexmedetomidine infusion then the Dexmedetomidine infusion stopped at the time of the tourniquet deflation.

Drug: Lidocaine 2% Injectable Solution

Interventions

Lidocaine 2% Injectable Solution DRUG

patients received Lidocaine 2%, 1 mg/kg, IV bolus over 10 mins after the induction of anaesthesia , followed by Lidocaine infusion (2 mg/kg/h) diluted in 50 ml of normal saline with a maximum dose of 200 mg/h. The tourniquet was inflated 10 minutes after the start of the Lidocaine infusion then the Lidocaine infusion stopped at the time of tourniquet deflation

dexmedetomidine group (group D)

Dexmedetomidine HCL Injection DRUG

patients received a loading dose of Dexmedetomidine-Pfizer (0.8 μg·kg-1 over 10 min) followed by continuous infusion of Dexmedetomidine (0.4 μg·kg-1.h-1) diluted in 50 ml of normal saline. The tourniquet was inflated 10 mins after the start of Dexmedetomidine infusion then the Dexmedetomidine infusion stopped at the time of the tourniquet deflation.

lidocaine group (group L)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients (males and females) of ASA class I or II, age from 18-60 years old, undergoing ambulatory knee arthroscopy under general anaesthesia using tourniquet.

You may not qualify if:

• Patients with uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension, and chronic obstructive lung disease),
• Patients with significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
• Patients with morbid obesity (BMI \>35).
• Patients with a history of allergy to the drugs used in this study.
• Patients who have history of chronic use of opioids.
• Cases with tourniquet times of less than 60 minutes or longer than 150 minutes were excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Hospital- Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

Lidocaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia , surgical ICU and pain -cairo university

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: March 1, 2025
• Primary Completion: March 14, 2026
• Study Completion: March 14, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)