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

• 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.

Study Overview

• Status: Completed
• Conditions: Agitation, Emergence
• Intervention / Treatment: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"

Detailed Description

The incidence of emergence agitation (EA) after nasal surgeries is relatively high , it is reported to be 68% (1).The precise mechanism is not known. Awake extubation after nasal surgeries is preferred as the airway may be contaminated by blood , and the nasal airway may be blocked by surgical packs that causes sense of suffocation. Awake extubation and nasal pack is a trigger to emergence agitation(2).

emergence agitation (EA) is harmful to the patient and the staff, it Characterized by disorientation, confusion, abnormal violent movement that may result in serious complication and morbidity(3). It develops early with the recovery from general anesthesia(4). Although agitation is more observed in pediatrics but its incidence in adults reach up to 21.4% (5).

Different medication agents such as anesthetic drugs, benzodiazepine and α2 agonist was proved to attenuate the EA with different efficiencies (6).

Dexmedetomidine is a selective α2 adrenoceptor agonist. It has sedative, hypnotic, anxiolytic, analgesic and sympatholytic properties. It was proved to reduce the EA in children(7). However there was few data about its effect in reducing the agitation in adult after general anesthesia(8).

Propofol is short acting hypnotic and sedative agent. It is used for induction and maintenance of anesthesia(9). Previous studies proved that propofol was effective in preventing EA (10,11) and depends on the time of administration(12).

Ketamine is N-methyl- D-asparate receptor antagonist, it has anesthetic, sedative and analgesic effect(13).

Ketofol is a combination of low dose ketamine with propofol , it has been used for sedation and analgesia. The effect of this combination was supposed to produce less toxicity compared to each drug alone by decreasing the required doses(14).

Ketodex is combined low dose of ketamine and dexmedetomidine, it was used for sedation , this combination decrease some of the pitfalls occurring when use dexmedetomidine as a sole agent(15).

Most EA studies was done in pediatric. To our knowledge there was no previous studies report the effect of bolus dose of ketodex versus ketofol on the incidence and prevention of EA after nasal surgeries in adults. This study aimed to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In adults Undergoing nasal surgeries.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Elsharkia
    • Zagazig, Elsharkia, Egypt, 022/055
      • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ketodex; ketamine dexmedetomidine mixture	Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"; 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.; Other Names: diprivan; precedex; ketalar
Active Comparator: ketofol; ketamine propofol mixture	Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"; 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.; Other Names: diprivan; precedex; ketalar
Placebo Comparator: placebo; normal saline	Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"; 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.; Other Names: diprivan; precedex; ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Emergence time	The time from discontinuation of isoflurane to first response to verbal command.	up to 20 minutes after discontinuation of isoflurane
The extubation time	time from discontinuation of isoflurane to extubation.	up to 20 minutes after discontinuation of isoflurane
The time of discharge	The time from arrival to postanesthesia care unite (PACU) to discharge to the ward according to modified aldert score	up to 40 minutes after extubation
Postoperative Pain is evaluated using Numerical rating Scale (NRS)	(NRS) A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.	up to 40 minutes after extubation
"Number of Participants with vomiting or hypotension or bradycardia"	vomiting , hypotension, bradycardia Vomiting	all over 40 minutes post-operative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Olfat Amin, M.D, Faculty of medicine, Zagazig university

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 23, 2019

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ketodex, ketofol , agitation , nasal surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Propofol; Dexmedetomidine
• Other Study ID Numbers: 5452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No