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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06791811
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Kasr El Aini Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Rania Samir, professor
Principal Investigator Affiliation Department of anaesthesia
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Supra-tentorial Tumor
Arms & Interventions

Arms

Active Comparator: Opioid free Anaesthesia group (OFA)

Prior to the induction of anesthesia the patients in OFA group will receive Dexmedetomidine and Lidocaine.

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.

Interventions

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)

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Cairo University, Cairo, Egypt

Status

Recruiting

Address

Cairo University

Cairo, , 11742

Stay Informed & Connected