Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Jordanian Royal Medical Services

Status and phase: Completed; Phase 2

Conditions: Agitation, Emergence

Treatments: Drug: Ketamine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05313659

postoperative agitation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 193 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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193 participants in 2 patient groups

group-K

Experimental group

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

Treatment:

Drug: Ketamine Hydrochloride

group-S

No Intervention group

Description:

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