Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries

NCT04018157 | Completed Early Phase 1

• 1 other identifier: 5452
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

• emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs more staff and nurses to control their abnormal movement which leads to self extubation , removal of catheters and bruises in the extremities.
• Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to prevent EA . Recently, ketodex is found to reduce the incidence and severity of EA .
• We aim to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of emergence Agitation in adults undergoing nasal surgeries.

Conditions

Agitation, Emergence

Keywords

ketodex, ketofol , agitation , nasal surgery

Outcome Measures

Primary Outcomes (2)

• The incidence of emergence agitation.

  The incidence of emergence agitation.

  up to 60 minutes after extubation

• The level of emergence agitation.

  The level of emergence agitation measured by . Richmond Agitation-Sedation scale (RASS) is ten scales; five for sedation level ,one for alertness and calmness, and four for agitation level as follow: -5 unarousable , -4 deep sedation , -3 moderate sedation , -2 light sedation , -1 drowsy ; 0 alert and calm,+1 restless , +2 agitated , +3 very agitated and +4 combative. Patients with score ≥ 2 considered having agitation.

  up to 60 minutes after extubation

Secondary Outcomes (5)

• The Emergence time

  up to 20 minutes after discontinuation of isoflurane

• The extubation time

  up to 20 minutes after discontinuation of isoflurane

• The time of discharge

  up to 40 minutes after extubation

• Postoperative Pain is evaluated using Numerical rating Scale (NRS)

  up to 40 minutes after extubation

• "Number of Participants with vomiting or hypotension or bradycardia"

  all over 40 minutes post-operative

Study Arms (3)

ketodex

ACTIVE COMPARATOR

ketamine dexmedetomidine mixture

Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"

ketofol

ACTIVE COMPARATOR

ketamine propofol mixture

Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"

placebo

PLACEBO COMPARATOR

normal saline

Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"

Interventions

"Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" DRUG

patients will receive single intravenous bolus of combination from ketamine 0.5mg/kg and dexmedetomidine 1ug/kg in one syringe diluted in 10 ml 0.9% saline.

Also known as: ketalar, precedex, diprivan

ketodex; ketofol; placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient acceptance.
• Both gender.
• Age (21-60) years old.
• patient with Body Mass Index (BMI) (25-35kg/m²).
• American Society of Anesthesiologist (ASA) I / II
• Adult patient scheduled to elective nasal surgeries

You may not qualify if:

• \- Patient with difficult airway (mallampati III,IV).
• Altered mental status (psychiatric and anxiety disorder).
• Post traumatic stress disorders.
• History of allergy to study drugs.
• Patient on sedative or hypnotic medication.
• Patients with chronic pain or on painkiller.
• Patients with severe hepatic or kidney impairment.
• Patients having a history of thyrotoxicosis, hypertension, cardiac , chest or neurological disease.
• Patient receiving B agonist.
• Pregnant or breast feeding female.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Elsharkia, 022/055, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium; Psychomotor Agitation

Interventions

Ketamine; Dexmedetomidine; Propofol; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Psychomotor Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Olfat Amin, M.D

  Faculty of medicine, Zagazig university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patient and outcomes assessor
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 12, 2019
• Study Start: July 3, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 23, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)