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

NCT ID: NCT04018157

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2019-11-23

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.

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.

Conditions

Agitation, Emergence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ketodex

ketamine dexmedetomidine mixture

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

ketofol

ketamine propofol mixture

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

placebo

normal saline

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

"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.

Intervention Type: DRUG

Other Intervention Names

ketalar; precedex; diprivan

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

olfat abd elmoniem ibrahem

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olfat Amin, M.D

Role: PRINCIPAL_INVESTIGATOR

Faculty of medicine, Zagazig university

Locations

Faculty of Medicine

Zagazig, Elsharkia, Egypt

Countries

Egypt

Other Identifiers

5452

Identifier Type: -

Identifier Source: org_study_id