Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Phase 2

Completed

• Conditions: Agitation, Emergence
• Interventions: Drug: Ketamine Hydrochloride

• Registration Number: NCT05313659
• Lead Sponsor: Jordanian Royal Medical Services

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.

Study Timeline

• Study First Submitted: 2022-03-20
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Start: 2022-05-11
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group-K	Ketamine Hydrochloride	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

Primary Outcome Measures

Name	Time	Method
Development of Agitation	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.

Trial Locations

Locations (1)

Jordanian Royal Medical Services; 🇯🇴 Amman, Jordan