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

Primary Purpose

Agitation, Emergence

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
"Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation, Emergence focused on measuring ketodex, ketofol , agitation , nasal surgery

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

ketodex

ketofol

placebo

Arm Description

ketamine dexmedetomidine mixture

ketamine propofol mixture

normal saline

Outcomes

Primary Outcome Measures

The incidence of emergence agitation.
The incidence of emergence agitation.
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.

Secondary Outcome Measures

The Emergence time
The time from discontinuation of isoflurane to first response to verbal command.
The extubation time
time from discontinuation of isoflurane to extubation.
The time of discharge
The time from arrival to postanesthesia care unite (PACU) to discharge to the ward according to modified aldert score
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.
"Number of Participants with vomiting or hypotension or bradycardia"
vomiting , hypotension, bradycardia Vomiting

Full Information

First Posted
July 4, 2019
Last Updated
November 25, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04018157
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Emergence
Keywords
ketodex, ketofol , agitation , nasal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
patient and outcomes assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketodex
Arm Type
Active Comparator
Arm Description
ketamine dexmedetomidine mixture
Arm Title
ketofol
Arm Type
Active Comparator
Arm Description
ketamine propofol mixture
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
normal saline
Intervention Type
Drug
Intervention Name(s)
"Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
Other Intervention Name(s)
ketalar, precedex, diprivan
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of emergence agitation.
Description
The incidence of emergence agitation.
Time Frame
up to 60 minutes after extubation
Title
The level of emergence agitation.
Description
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.
Time Frame
up to 60 minutes after extubation
Secondary Outcome Measure Information:
Title
The Emergence time
Description
The time from discontinuation of isoflurane to first response to verbal command.
Time Frame
up to 20 minutes after discontinuation of isoflurane
Title
The extubation time
Description
time from discontinuation of isoflurane to extubation.
Time Frame
up to 20 minutes after discontinuation of isoflurane
Title
The time of discharge
Description
The time from arrival to postanesthesia care unite (PACU) to discharge to the ward according to modified aldert score
Time Frame
up to 40 minutes after extubation
Title
Postoperative Pain is evaluated using Numerical rating Scale (NRS)
Description
(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.
Time Frame
up to 40 minutes after extubation
Title
"Number of Participants with vomiting or hypotension or bradycardia"
Description
vomiting , hypotension, bradycardia Vomiting
Time Frame
all over 40 minutes post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olfat Amin, M.D
Organizational Affiliation
Faculty of medicine, Zagazig university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Zagazig
State/Province
Elsharkia
ZIP/Postal Code
022/055
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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