Opioid Free VS Opioid Anesthesia for Craniotomies

NCT04941040 | Completed Phase 1

• 1 other identifier: N 56-2016/MD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hemodynamic control during craniotomies can be a bit hectic specially during periods of intense noxious stimulation. For long anesthesiologists used high doses of opioids such as fentanyl and remifentanyl to provide analgesia with a good hemodynamic control during intraoperative period in patients undergoing craniotomies. However, the use of opioids was not devoid of side effects. Exploring other anesthetic plans using multiple opioid free anesthetic adjuvants that have analgesic effects given together in small doses appear to be appealing plan. This idea is the basis of our proposed study in which we compare the hemodynamic effects of using opioid free anesthesia versus opioid anesthesia in cranial surgeries.

Conditions

Supratentorial Neoplasms

Keywords

Opioid free Anesthesia; Craniotomies; Dexmedetomidine; Ketamine; Fentanyl; Lidocaine; Magnesium sulphate; supratentorial tumors

Outcome Measures

Primary Outcomes (1)

• Percentage of patients experiencing a change in mean arterial pressure at time of Burr Hole

  Defined as recording an increase or decrease of the mean arterial blood pressure by more than 25 % from baseline readings at the time of burr hole

  During Burr hole surgery

Secondary Outcomes (8)

• HR (heart rate) in beats/min

  Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU.

• Brain relaxation score

  At the time of dural incision

• Number of patients requiring antihypertensive medication

  Throughout the operation

• Number of patients requiring medication to increase blood pressure

  Throughout the operation

• Time to extubation

  At the end of the operation, the time from the discontinuation of inhalation agents till extubation

Study Arms (2)

Opioid free anesthesia

EXPERIMENTAL

patients are going to receive intraoperative analgesics other than opioids

Drug: Opioid free anesthetics

Opioid anesthesia

ACTIVE COMPARATOR

patients are going to receive intraoperative opioid analgesics

Drug: Opioid Anesthetics

Interventions

Opioid free anesthetics DRUG

Patients will receive over the 10 minutes prior to induction: * Acetaminophen 1 gm i.v. infusion in 100ml over 10 minutes. * Ketorolac 30 mg i.v. infusion in100 ml over 10 minutes. * Mg SO4 loading dose 30 mg/kg i.v. infusion in 100 ml over 10 minutes. * Dexmedetomidine loading dose 1 μg/kg i.v. infusion. * Lidocaine loading dose 1.5 mg/kg i.v. infusion. * Ketamine loading dose 0.25 mg/kg i.v. infusion. The weight based doses of dexmedetomidine, lidocaine, ketamine will be prepared on 20 ml syringe and infused over 10 minutes prior to induction. In a dose of 0.1 ml/kg Then after induction maintenance analgesic infusion will start in a rate that ranges from 0.025 to 0.05 ml/kg/h which is equivalent to: * Dexmedetomidine 0.25-0.5 μg/kg/h * Lidocaine 0.375-0.75 mg/kg/h * Ketamine 0.0625- 0.125 mg/kg/h

Also known as: OFA

Opioid free anesthesia

Opioid Anesthetics DRUG

Placebo equivalent to acetaminophen, ketorolac, magnesium sulphate will be infused as 100 ml normal saline each over 10 minutes ,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.

Also known as: OA

Opioid anesthesia

Eligibility Criteria

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

You may qualify if:

• ASA Ι and II.
• Patients undergoing surgeries for removal of supratentorial tumors.
• Age (18-60) years.
• Both sexes.

You may not qualify if:

• Impaired renal functions.
• Systemic hypertension.
• Dysrhythmia.
• Heart failure.
• Glasgow coma scale less than 12.
• The need for postoperative ventilation.
• History of allergy to the study drugs.
• Surgeries lasting more than 6 hours.
• Pregnancy.
• Bronchial asthma

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, 11687, Egypt

Location

Related Publications (7)

• Uyar AS, Yagmurdur H, Fidan Y, Topkaya C, Basar H. Dexmedetomidine attenuates the hemodynamic and neuroendocrinal responses to skull-pin head-holder application during craniotomy. J Neurosurg Anesthesiol. 2008 Jul;20(3):174-9. doi: 10.1097/ANA.0b013e318177e5eb.

  PMID: 18580347 BACKGROUND

• Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.

  PMID: 10861145 BACKGROUND

• Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.

  PMID: 16508405 BACKGROUND

• Mulier JP. Perioperative opioids aggravate obstructive breathing in sleep apnea syndrome: mechanisms and alternative anesthesia strategies. Curr Opin Anaesthesiol. 2016 Feb;29(1):129-33. doi: 10.1097/ACO.0000000000000281.

  PMID: 26595546 BACKGROUND

• Cortinez LI, Hsu YW, Sum-Ping ST, Young C, Keifer JC, Macleod D, Robertson KM, Wright DR, Moretti EW, Somma J. Dexmedetomidine pharmacodynamics: Part II: Crossover comparison of the analgesic effect of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1077-83. doi: 10.1097/00000542-200411000-00006.

  PMID: 15505442 BACKGROUND

• Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.

  PMID: 19138915 BACKGROUND

• Syeda 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.

  PMID: 33171574 BACKGROUND

MeSH Terms

Conditions

Supratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rania S Fahmy

  Kasr Al Ainy, Faculty of medicine, Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia, ICU and pain medicine

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 28, 2021
• Study Start: July 5, 2021
• Primary Completion: October 3, 2021
• Study Completion: October 3, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)