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

NCT ID: NCT07002073

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-02-15

Brief Summary

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

Detailed Description

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This study details the protocol for anesthetic induction and maintenance, allocating patients into Ketodex (KD) and Ketofol (KP) groups. Prior to anesthesia, a fluid challenge (4 mL/kg over 10 minutes) was administered to assess volume status, with repeated challenges until pulse pressure increased by less than 15% of baseline. For induction, all patients received 1 mg/kg lidocaine. KD patients then received 1 mg/kg ketamine + 0.5 µg/kg dexmedetomidine over 10 minutes, while KP patients received 0.15-0.20 mL/kg of a ketofol admixture. Loss of consciousness, defined by no response to auditory commands and absent eyelash reflex, led to the administration of 0.6 mg/kg rocuronium. After 2 minutes of mask ventilation, an endotracheal tube was inserted. Anesthesia was maintained with isoflurane (0.9-1% end-tidal), and Ringer's lactate solution was infused at 4 mL/kg/hour. Hemodynamic stability was rigorously managed: hypotension (mean blood pressure (MBP) ≤ 80% of baseline and/or MBP \< 60 mmHg) occurring up to 15 minutes post-intubation or skin incision was treated with 5 µg norepinephrine boluses, repeatable every 2 minutes. Severe post-induction hypotension (MBP ≤ 60% of baseline) prompted 5 µg norepinephrine boluses every minute, with 1-minute interval blood pressure monitoring. Hypertension (mean arterial pressure \> 120% of baseline) was managed with 0.25 mg/kg IV propofol, while bradycardia (heart rate \< 45 bpm) was treated with 0.5 mg IV atropine. Blood pressure and heart rate were continuously monitored at specified intervals, with subsequent hemodynamic management left to the discretion of the attending anesthetist after 15 minutes post-intubation or skin incision.

Conditions

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Ketamine-dexmedetomidine Induction of Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ketamine-dexmedetomidine admixture induction of Anesthesia

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

Group Type ACTIVE_COMPARATOR

Intravenous Induction of Anesthesia

Intervention Type DRUG

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

propofol - ketamine admixture induction of Anesthesia

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

Group Type ACTIVE_COMPARATOR

Intravenous Induction of Anesthesia

Intervention Type DRUG

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

Interventions

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Intravenous Induction of Anesthesia

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

Intervention Type DRUG

Other Intervention Names

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Effect of drug mixtures on hypotension during induction of Anesthesia in elderly patients

Eligibility Criteria

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Inclusion Criteria

* Elderly patients (\>65 years)
* ASA physical status I-III
* Elective non-cardiac surgery under general anesthesia.

Exclusion Criteria

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emad Mohamed Ahmed Abdelhafez

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University Hospitals

Cairo, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Emad M. Abdelhafez, MD

Role: CONTACT

[email protected]
00201096324748

Hadir K. Mohamed Ahmed, M.Sc..

Role: CONTACT

[email protected]
00201004232979

Facility Contacts

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Emad M. Abdelhafez, Lecturer

Role: primary

[email protected]
00201096324748

Other Identifiers

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MD-451-2024

Identifier Type: -

Identifier Source: org_study_id