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Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Primary Purpose

Agitation, Emergence

Status
Completed
Phase
Phase 2
Locations
Jordan
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
Jordanian Royal Medical Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation, Emergence focused on measuring Agitation, Emergence, Ketamine, Intramuscular, Nasal surgery

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jordanian Royal Medical Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group-K

group-S

Arm Description

At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K

At the end of surgery and immediately after the inhalational agent was discontinued, 2 mL of normal saline was administered intramuscularly.

Outcomes

Primary Outcome Measures

Development of Agitation
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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2022
Last Updated
January 23, 2023
Sponsor
Jordanian Royal Medical Services
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1. Study Identification

Unique Protocol Identification Number
NCT05313659
Brief Title
Intramuscular Ketamine Effect on Postnasal Surgery Agitation
Official Title
Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordanian Royal Medical Services

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 (EA) is a common complication after nasal surgery. In this study, we aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery. Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after extubation.
Detailed Description
At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3 ml syringe. The injection site of both groups was at the lateral thigh. For postoperative analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated. The EA level of the patients was evaluated immediately after extubation till the patient was handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the highest score was documented by the main investigators. In this study patients with a RASS score of +2 or more were considered to have EA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Emergence
Keywords
Agitation, Emergence, Ketamine, Intramuscular, Nasal surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group-K
Arm Type
Experimental
Arm Description
At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to Group-K
Arm Title
group-S
Arm Type
No Intervention
Arm Description
At the end of surgery and immediately after the inhalational agent was discontinued, 2 mL of normal saline was administered intramuscularly.
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off
Primary Outcome Measure Information:
Title
Development of Agitation
Description
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.
Time Frame
immediately After extubation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age group 18-64 years old ASA I-II BMI 20-29.9 Patients accepting the study and consenting Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty. Exclusion Criteria: ketamine allergy Morphine allergy History of cardiac, neurological, or psychiatric disease, glaucoma, Patients with a body mass index of less than 20 or more than 30 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Husam A. Almajali, MD
Organizational Affiliation
Jordanian Royal Medical Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali M. Abu Dalo, MD
Organizational Affiliation
Jordanian Royal Medical Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordanian Royal Medical Services
City
Amman
ZIP/Postal Code
11855
Country
Jordan

12. IPD Sharing Statement

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Intramuscular Ketamine Effect on Postnasal Surgery Agitation

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