A Comparative Study Between Opioids Free Anesthesia and Opioid Anesthesia in Patients With Supratentorial Tumor Resection

December 11, 2025 updated by: Sherif Alaa Embaby, Kasr El Aini Hospital

A Comparative Study Between Opioids Free Anesthesia Using Dexmedetomidine and Lidocaine and Conventional Opioid Anesthesia on Stress Points Haemodynamics in Patients Undergoing Supratentorial Tumor Resection

Anesthesia for cranial surgeries is charactarized by periods of unpleasant stimuli interspersed with periods of low stimulation, which may compromise hemodynamic regulation.

Intraoperative and early postoperative episodes of hypertension during moments of strong stimulation can cause major consequences such as post craniotomy intracranial haemorrhage and vasogenic brain edema.

The use of powerful opioid analgesics like fentanyl and remifentanil in increasing doses for anaesthesia is a common practice among anesthesiologists.However, using strong opioids continuously or in bolus doses during surgery may result in postoperative hyperalgesia and higher analgesic need.

More recently, concerns have risen about impaired healing, immunosuppression , worsening of oncologic outcomes with systemic opioids and may affect conscious level at time of extubation (3).

Opioid-free anaesthesia(OFA) is increasingly gaining acceptance among anaesthesioligists. Its mainstay is based on a number of analgesic adjuvants that, when combined in small dosages, will produce effective anaesthesia with fewer side effects and a quicker recovery time than opioids. This approach, which combines several medications including dexmedetomidine, lidocaine, ketamine, ketorolac, and magnesium, has been used successfully in anaesthesia for bariatric procedures (3) . In cranial surgerie,OFA has been mainly used in pilot studies and case reports and their main focus was postoperative opioid consumption and not intraoperative haemodynamics.(4).

Dexmedetomidine which is a highly selective 2-adrenoceptor agonist has positive effects as anesthetic adjuvant.It has sedative, anxiolytic, and analgesic effects with little impact on respiratory drive, Dexmedetomidine analgesic properties are less potent than opioids, despite the fact that preoperative intravenous dexmedetomidine administration is linked to a reduction in postoperative pain intensity, analgesic intake, and nausea.

According to reports, intravenous lidocaine possesses analgesic, anti-hyperalgesic, and anti-inflammatory actions by inhibition of the priming of resting neutrophilic granulocytes which may reduce the liberation of superoxide anions a common pathway of inflammation. It has potentials for brain protections as it reduces cerebral oxygen consumption, cerebral blood volume and flow .Moreover ,it decreases the intracranial pressure and consequently results in brain relaxation.

The addition of a scalp block to general anaesthetic during craniotomies might lessen the discomfort associated with scalp incision and pin application, as well as the need for analgesics such as opioids or anaesthesia adjuvants, encouraging early recovery for neurological evaluation. The usage of this block has increased as a result of recent developments in neurosurgery, particularly awake craniotomy.

To our knowledge ,the effects of continuous intravenous lidocaine and dexmedetomidine infusion on hemodynamics, brain relaxation and surgeon satisfaction in adult patients undergoing cranial surgeries for tumor excision without the use of opioids, however, have not been studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11742
        • Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ASA Ι and II.
  2. Patients undergoing resection of supratentorial tumors in supine position.
  3. Age (18-50) years.
  4. Both sexes.

Exclusion Criteria:

  1. Impaired renal functions.
  2. Uncontrolled systemic hypertension(patients with sustained elevated blood pressure more than 140/90).
  3. Cardiac arrhythmias (any rhythm other than normal sinus rhythm and sinus tachycardia).
  4. Heart failure(impaired cardiac contractility ,EF less than 45%.).
  5. Patients receiving more than 2 units of blood during surgery.
  6. Patients with large masses and expected severe increase in ICP.
  7. Patients requiring vasopressors infusion.
  8. The need for postoperative ventilation at the end of study.
  9. Glasgow coma scale less than 14.
  10. History of allergy to the study drugs.
  11. Surgeries lasting more than 4 hours.
  12. Pregnancy.
  13. Bronchial asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opioid free Anaesthesia group (OFA)
Prior to the induction of anesthesia the patients in OFA group will receive Dexmedetomidine and Lidocaine.
Other: OFA

Prior to the induction of anesthesia the patients in OFA group will receive Dexmedetomidine loading dose 1 μg/kg i.v. infusion, and Lidocaine loading dose 1.5 mg/kg i.v. infusion.

The weight based doses of dexmedetomidine, lidocaine will be prepared in a 20 ml syringe and infused over 10 minutes prior to induction.

Then after induction maintenance drugs will be infused as follow:

Dexmedetomidine 0.25-0.5 μg/kg/h (200 micogram in 50cc syrige with infusion rate 0.125-0.250ml/kg/h), and Lidocaine 2mg/kg/h (400mg in 20cc syringe with infusion rate 0.1 ml/kg/h)
Active Comparator: Opioid Anaesthesia group (OA).
In the opioid anaesthesia group patients will receive fentanyl 2 μg/kg loading dose which will be prepared over 20 ml syringe and infused over 10 minutes prior to induction, Then after induction maintenance of analgesic infusion by fentanyl 0.5-1 μg/kg/h (200 micograms in 50 cc syringe with infusion rate 0.125-0.250ml/kg/h).Placebo (saline infusion) in 20 cc syringe with rate infusion rate 0.1 ml/kg/h.
Other: OA
In the opioid anaesthesia group patients will receive fentanyl 2 μg/kg loading dose which will be prepared over 20 ml syringe and infused over 10 minutes prior to induction, Then after induction maintenance of analgesic infusion by fentanyl 0.5-1 μg/kg/h (200 micograms in 50 cc syringe with infusion rate 0.125-0.250ml/kg/h).Placebo (saline infusion) in 20 cc syringe with rate infusion rate 0.1 ml/kg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patents experiencing a change in mean arterial pressure at time of Burr Hole
Time Frame: During the bur hole procedure around 20-30 minutes
Percentage of patients experiencing a change in mean arterial pressure at time of Burr Hole ( Time Frame :During Burr hole surgery) Defined as recording an increase of the mean arterial blood pressure by more than 20% from baseline readings at time of burr hole.
During the bur hole procedure around 20-30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Investigators

  • Study Director: Rania Samir, professor, Department of anaesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

August 30, 2025

Study Registration Dates

First Submitted

September 7, 2024

First Submitted That Met QC Criteria

January 19, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-83-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the data related to the study would be available.

IPD Sharing Time Frame

1 month after the study is published.

IPD Sharing Access Criteria

Any relatable study with an official request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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