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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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ClinicalTrials.gov Identifier: NCT04018157
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
olfat abd elmoniem ibrahem, Zagazig University

Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE July 3, 2019
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • The incidence of emergence agitation. [ Time Frame: up to 60 minutes after extubation ]
    The incidence of emergence agitation.
  • The level of emergence agitation. [ Time Frame: up to 60 minutes after extubation ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • The incidence of emergence agitation. [ Time Frame: 24 hours postoperative ]
    The incidence of emergence agitation.
  • 1- Emergence time [ Time Frame: up to 60 minutes postoperative ]
    time from discontinuation of isoflurane to first response to verbal command.
  • 2- The extubation time [ Time Frame: up to 60 minutes postoperative ]
    time from discontinuation of isoflurane to extubation.
  • 3- change in the level of emergence agitation is assessed by Richmond Agitation-Sedation scale (RASS) [ Time Frame: Change in the level of emergence agitation " in the first 60 minutes" postoperative, and "every 10 minutes in the first 30 minutes", then "every 15 minutes up to 120 minutes", then "at 4 hours"," 6 hours", "12hours", "24 hours". ]
    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.
  • 4- Postoperative Pain is evaluated using Numerical rating Scale (NRS) [ Time Frame: Change at "30 minutes", "2hours", "4hours", "6hours", "12hours", and "24hours " postoperative ]
    (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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • The Emergence time [ Time Frame: up to 20 minutes after discontinuation of isoflurane ]
    The time from discontinuation of isoflurane to first response to verbal command.
  • The extubation time [ Time Frame: up to 20 minutes after discontinuation of isoflurane ]
    time from discontinuation of isoflurane to extubation.
  • The time of discharge [ Time Frame: up to 40 minutes after extubation ]
    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) [ Time Frame: up to 40 minutes after extubation ]
    (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" [ Time Frame: all over 40 minutes post-operative ]
    vomiting , hypotension, bradycardia Vomiting
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • The time of discharge [ Time Frame: up to 120 minutes postoperative ]
    The time from arrival to postanesthesia care unite (PACU) to discharge to the ward according to modified aldert score
  • mean arterial pressure [ Time Frame: on admission to PACU , and "at 10 minutes in the first 30 minutes", then "every 15 minutes up to 120 minutes", and at "4 hours", "6 hours", "12hours", "24 hours" ]
    mean arterial pressure mmHg
  • Side effects [ Time Frame: up to 24 hours postoperative ]
    nausea , Vomiting
  • Heart rate [ Time Frame: on admission to PACU , and "at 10 minutes in the first 30 minutes", then "every 15 minutes up to 120 minutes", and at "4 hours", "6 hours", "12hours", "24 hours" ]
    Heart rate beats/minutes
  • Oxygen saturation [ Time Frame: on admission to PACU , and "at 10 minutes in the first 30 minutes", then "every 15 minutes up to 120 minutes", and at "4 hours", "6 hours", "12hours", "24 hours" ]
    Oxygen saturation percentage
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
Official Title  ICMJE Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
patient and outcomes assessor
Primary Purpose: Prevention
Condition  ICMJE Agitation, Emergence
Intervention  ICMJE 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:
  • ketalar
  • precedex
  • diprivan
Study Arms  ICMJE
  • Active Comparator: ketodex
    ketamine dexmedetomidine mixture
    Intervention: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
  • Active Comparator: ketofol
    ketamine propofol mixture
    Intervention: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
  • Placebo Comparator: placebo
    normal saline
    Intervention: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 23, 2019
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018157
Other Study ID Numbers  ICMJE 5452
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party olfat abd elmoniem ibrahem, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olfat Amin, M.D Faculty of medicine, Zagazig university
PRS Account Zagazig University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP