NCT05313659

Intramuscular Ketamine Effect on Postnasal Surgery Agitation

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Jordanian Royal Medical Services · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Agitation, Emergence

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-10-20
• Completion: 2022-10-20
• First posted: 2022-04-06
• Last updated: 2023-01-25

Locations

1 site across 1 country: Jordan