Supra-tentorial TumorNCT06791811
A Comparative Study Between Opioids Free Anesthesia and Opioid Anesthesia in Patients With Supratentorial Tumor Resection
A study testing OFA and OA in people with Supra-tentorial Tumor, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Supra-tentorial Tumor
- What is being tested?
- OFA and OA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA Ι and II.
- Patients undergoing resection of supratentorial tumors in supine position.
- Age (18-50) years.
- Both sexes.
Who cannot join
- Impaired renal functions.
- Uncontrolled systemic hypertension(patients with sustained elevated blood pressure more than 140/90).
- Cardiac arrhythmias (any rhythm other than normal sinus rhythm and sinus tachycardia).
- Heart failure(impaired cardiac contractility ,EF less than 45%.).
- Patients receiving more than 2 units of blood during surgery.
- Patients with large masses and expected severe increase in ICP.
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- Patients requiring vasopressors infusion.
- The need for postoperative ventilation at the end of study.
- Glasgow coma scale less than 14.
- History of allergy to the study drugs.
- Surgeries lasting more than 4 hours.
- Pregnancy.
- Bronchial asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Supra-tentorial Tumor
- Being tested
- OFA, OA
- Keywords
- Anaesthesia, dexmedetomidine, Craniotomy, Lidocaine, Opioid Free Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFAOther
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)
OAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid free Anaesthesia group (OFA) | Active comparator | Prior to the induction of anesthesia the patients in OFA group will receive Dexmedetomidine and Lidocaine. Receives: Other: OFA |
| Opioid Anaesthesia group (OA). | Active comparator | 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. Receives: Other: OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patents experiencing a change in mean arterial pressure at time of Burr Hole
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.
Measured: During the bur hole procedure around 20-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Mar 2025
- Primary completion30 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supra-tentorial TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Alaa Embaby, Kasr El Aini Hospital
- Investigators
- Rania Samir, professor, Study director, Department of anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791811
- Sponsor's protocol ID
- MD-83-2024
- Status last verified
- Dec 2025
- First submitted
- 7 Sep 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data related to the study would be available.
Publications
Chandra S, Pryambodho P, Omega A. Evaluation of continuous intravenous lidocaine on brain relaxation, intraoperative opioid consumption, and surgeon's satisfaction in adult patients undergoing craniotomy tumor surgery: A randomized controlled trial. Medicine (Baltimore). 2022 Sep 9;101(36):e30216. doi: 10.1097/MD.0000000000030227.
PubMed 36086723Syeda S, Palaniswamy SR, Sriganesh K. Opioid Free Analgesia With Dexmedetomidine for Craniotomy in an Obese Patient With Obstructive Sleep Apnea and Difficult Airway. Asian J Anesthesiol. 2020 Jun 1;58(2):76-77. doi: 10.6859/aja.202006_58(2).0007. Epub 2020 Jul 24. No abstract available.
PubMed 33171574
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06791811
- Acronym / sponsor ID
- MD-83-2024
- Conditions
- Supra-tentorial Tumor
- Keywords
- Anaesthesia, dexmedetomidine, Craniotomy, Lidocaine, Opioid Free Anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid free Anaesthesia group (OFA) | Active comparator | Other: OFAPrior to the induction of anesthesia the patients in OFA group will receive Dexmedetomidine and Lidocaine. |
| Opioid Anaesthesia group (OA). | Active comparator | Other: OAIn 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA Ι and II.
- Patients undergoing resection of supratentorial tumors in supine position.
- Age (18-50) years.
- Both sexes.
Key exclusion criteria (13 listed)
- Impaired renal functions.
- Uncontrolled systemic hypertension(patients with sustained elevated blood pressure more than 140/90).
- Cardiac arrhythmias (any rhythm other than normal sinus rhythm and sinus tachycardia).
- Heart failure(impaired cardiac contractility ,EF less than 45%.).
- Patients receiving more than 2 units of blood during surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OFAPrior 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 | Opioid free Anaesthesia group (OFA) |
| OAIn 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 | Opioid Anaesthesia group (OA). |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 36086723Chandra S, Pryambodho P, Omega A. Evaluation of continuous intravenous lidocaine on brain relaxation, intraoperative opioid consumption, and surgeon's satisfaction in adult patients undergoing craniotomy tumor surgery: A randomized controlled trial. Medicine (Baltimore). 2022 Sep 9;101(36):e30216. doi: 10.1097/MD.0000000000030227.
- Background: PubMed 33171574Syeda S, Palaniswamy SR, Sriganesh K. Opioid Free Analgesia With Dexmedetomidine for Craniotomy in an Obese Patient With Obstructive Sleep Apnea and Difficult Airway. Asian J Anesthesiol. 2020 Jun 1;58(2):76-77. doi: 10.6859/aja.202006_58(2).0007. Epub 2020 Jul 24. No abstract available.
- Individual participant dataSharing planned: Yes. All the data related to the study would be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Samir, professor study director
Department of anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OFA and OA in people with Supra-tentorial Tumor, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.