Clinical trial NCT04018157: Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
Official title: Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Agitation, Emergence
Keywords: ketodex, ketofol , agitation , nasal surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The incidence of emergence agitation.
timeFrame: up to 60 minutes after extubation
measure: The level of emergence agitation.
timeFrame: up to 60 minutes after extubation
Secondary outcomes:
measure: The Emergence time
timeFrame: up to 20 minutes after discontinuation of isoflurane
measure: The extubation time
timeFrame: up to 20 minutes after discontinuation of isoflurane
measure: The time of discharge
timeFrame: up to 40 minutes after extubation
measure: Postoperative Pain is evaluated using Numerical rating Scale (NRS)
timeFrame: up to 40 minutes after extubation
measure: "Number of Participants with vomiting or hypotension or bradycardia"
timeFrame: all over 40 minutes post-operative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine
state: Elsharkia
Study officials:
affiliation: Faculty of medicine, Zagazig university
name: Olfat Amin, M.D
role: PRINCIPAL_INVESTIGATOR
References: