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Intramuscular Ketamine Effect on Postnasal Surgery Agitation

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ClinicalTrials.gov Identifier: NCT05313659
Recruitment Status : Recruiting
First Posted : April 6, 2022
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Husam A. Almajali, Jordanian Royal Medical Services

Tracking Information
First Submitted Date  ICMJE March 20, 2022
First Posted Date  ICMJE April 6, 2022
Last Update Posted Date May 31, 2022
Actual Study Start Date  ICMJE May 11, 2022
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2022)
Agitation [ Time Frame: immediately After extubation. ]
Using The Richmond agitation-sedation score. The score being from(-5) to (+4) ; 2 and more being agitated patients and less than 2 not agitated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intramuscular Ketamine Effect on Postnasal Surgery Agitation
Official Title  ICMJE Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.
Brief Summary Randomized study of ASA I-II patients, who will undergo elective nasal surgery( septoplasty and septorhinoplasty ) . The patients will be randomly divided into 2 groups: ketamine (group-K) and saline (control group) (group-S). At the time of turning the inhalational agent off , intramuscular racemic ketamine will be administered in a dose of 0.7 mg/kg, whereas group-s will receive intramuscular saline with same volume that would be administered if it was ketamine. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Agitation, Emergence
Intervention  ICMJE Drug: Ketamine Hydrochloride
intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off
Study Arms  ICMJE
  • Experimental: group-K
    Intervention: Drug: Ketamine Hydrochloride
  • No Intervention: group-S
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2022)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age group 18-64 years old
  2. ASA I-II
  3. BMI 20-29.9

Exclusion Criteria:

  1. drug abuse
  2. obesity (BMI equal or above 30)
  3. patient with diagnosed psychological problems
  4. preoperative agitation
  5. using sevoflurane to maintain anesthesia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Husam A. Almajali, MD +962799527892 dr.majali1@yahoo.com
Contact: Ali M. Abu Dalo, MD +962770765513 a.ad_91@yahoo.com
Listed Location Countries  ICMJE Jordan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05313659
Other Study ID Numbers  ICMJE postoperative agitation
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 Not Provided
Current Responsible Party Husam A. Almajali, Jordanian Royal Medical Services
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jordanian Royal Medical Services
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Husam A. Almajali, MD Jordanian Royal Medical Services
Principal Investigator: Ali M. Abu Dalo, MD Jordanian Royal Medical Services
PRS Account Jordanian Royal Medical Services
Verification Date May 2022

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