Opioid-based Versus Lidocaine-based Induction of Anesthesia With Propofol in Elderly

NCT05051007 | Unknown Phase 4

• 1 other identifier: MD-239-2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Advances in the medical service and public health increased longevity; hence, more elderly patients (\>65 years) are encountered by the anesthetists for variety of surgical interventions. Even with the absence of comorbidity, older patients represent a challenge to the anesthetist in comparison to the younger patients due to their limited physiologic reserve and their aberrant response to the varies perioperative medications. Intraoperative hypotension increases the risk of postoperative kidney injury, myocardial injury, cerebral ischemia, and perioperative mortality. Postinduction hypotension is mainly caused by anesthetic drugs. Hence, developing a technique for induction of anesthesia that provide adequate hypnosis with stable hemodynamics during surgery is critical, especially for elderly patients. The elderly patients are at increased risk of post-induction hypotension due to increased drug sensitivity. Propofol is the most commonly used drug for anesthesia induction; however, its use is usually associated with hypotension through vasodilation and direct myocardial depression. Opioid drugs are usually added as analgesics to propofol during induction of anesthesia. However, addition of opioids to propofol potentiates the risk of postinduction hypotension. Furthermore, opioids increase the risk of postoperative delirium in elderly patients and this risk is further increased with intraoperative hypotension. Lidocaine is a local anesthetic drug with multiple systemic uses. Lidocaine was proposed to have an anesthetic sparing effect. Lidocaine was previously reported to enhance the hypnotic effect of thiopentone, propofol, and midazolam during procedural sedation. Lidocaine/ketamine combination showed favorable hemodynamic profile following rapid-sequence induction of anesthesia in septic shock patients. Therefore, the use of lidocaine as an adjuvant to propofol might provide a stable cardiovascular profile during induction of anesthesia in elderly compared to fentanyl. To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with propofol in elderly

Conditions

Postinduction Hypotension; Elderly

Outcome Measures

Primary Outcomes (1)

• total norepinephrine dose

  mcg

  1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

Secondary Outcomes (8)

• Incidence of post-induction hypotension

  1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

• Incidence of severe post-induction hypotension

  1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

• Incidence of hypertension

  1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

• tachycardia

  1 minute after induction of anesthesia until 15 minutes after induction or surgical incision

• loss consciousness time

  1 second after starting drug injection until one second after loss of consciousness

Study Arms (2)

fentanyl group

ACTIVE COMPARATOR

Drug: fentanyl

lidocaine group

ACTIVE COMPARATOR

Drug: Lidocaine IV

Interventions

fentanyl DRUG

patients will receive 1 mcg/kg of fentanyl (the drug will be diluted to 10 mcg/mL)

fentanyl group

Lidocaine IV DRUG

patients will receive 1 mg/kg lidocaine (the drug will be diluted to10mg/mL)

lidocaine group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologists I-III,
• scheduled for elective non-cardiac surgery under general anesthesia

You may not qualify if:

• Patients with severe cardiac morbidities (impaired contractility with ejection fraction \< 50%, heart block, arrhythmias, tight valvular lesions, metabolic equivalent less than 4),
• patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications,
• patients with uncontrolled hypertension,
• patients with body mass index \<18 or \> 35 Kg/m2,
• patient with allergy of any of the study drugs

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

ahmed hasanin

CONTACT

01095076954; ahmedmohamedhasanin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

EG (1)