Comparison of the Hemodynamic Effects of Ketamine - Dexmedetomidine (Ketodex) Versus Propofol-ketamine Admixture (Ketofol) During Induction of Anesthesia in Elderly: A Randomized Comparative Study

NCT07002073 | Completed

• 1 other identifier: MD-451-2024
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the hemodynamic effects of Ketamine-Dexmedetomidine admixture (Ketodex) versus propofol-ketamine admixture (Ketofol) during induction of anesthesia in elderly

Conditions

Ketamine-dexmedetomidine Induction of Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of post-induction hypotension

  Incidence of post-induction hypotension (MBP ≤80% of baseline or \<60 mmHg) during the period from induction of anesthesia until 16-minutes after intubation providing that skin incision will be after 16-minutes interval.

  12 months

Study Arms (2)

ketamine-dexmedetomidine admixture induction of Anesthesia

ACTIVE COMPARATOR

Intravenous Induction of Anesthesia Using a Mixture of Ketamine and dexmedetomidine in a ratio of 1 mg ketamine to 0.5 ug dexmedetomidine given in a dose of 1mg/kg ketamine and 0.5 ug/kg dexmedetomidine to elderly patients

Drug: Intravenous Induction of Anesthesia

propofol - ketamine admixture induction of Anesthesia

ACTIVE COMPARATOR

Intravenous Induction of Anesthesia Using a Mixture of Ketamine and Propofol in a ratio of 1:1 in elderly patients given in a dose of 1 mg/kg ketamine and 1 mg/kg propofol

Drug: Intravenous Induction of Anesthesia

Interventions

Intravenous Induction of Anesthesia DRUG

To compare incidence of hypotension following ketodex versus ketofol during intavenous induction of general anesthesia in elderly patients

Also known as: Effect of drug mixtures on hypotension during induction of Anesthesia in elderly patients

ketamine-dexmedetomidine admixture induction of Anesthesia; propofol - ketamine admixture induction of Anesthesia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly patients (\>65 years)
• ASA physical status I-III
• 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 \[MET\] less than 4
• Patients on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers medications
• Patients with uncontrolled hypertension
• patients undergoing adrenalectomy
• patients with body mass index \<18 or \> 35 kg/m²
• patient with allergy to any of the study drugs.
• patient is considered to be a difficult intubation in the preoperative assessment.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Giza Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: April 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: February 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

EG (1)