Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Agitation, Emergence Clinical Trial

Official title:

Intramuscular Ketamine Effect on Postnasal Surgery Agitation: a Double Blinded Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05313659
• Other study ID #: postoperative agitation
• Status: Completed
• Phase: Phase 2
• Start date: May 11, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: January 2023
• Source: Jordanian Royal Medical Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Age group 18-64 years old

2. ASA I-II

3. BMI 20-29.9

4. Patients accepting the study and consenting

5. Undergoing general anesthesia for scheduled septoplasty or open septorhinoplasty.

Exclusion Criteria:

1. ketamine allergy

2. Morphine allergy

3. History of cardiac, neurological, or psychiatric disease, glaucoma,

4. Patients with a body mass index of less than 20 or more than 30 kg/m2

Related Conditions & MeSH terms

• Agitation, Emergence
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Ketamine Hydrochloride
intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off

Locations

Country	Name	City	State
Jordan	Jordanian Royal Medical Services	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Jordanian Royal Medical Services

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately After extubation.