Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Agitation, Emergence

Intervention / Treatment
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* Drug: Ketamine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group-K<br>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 | Drug: Ketamine Hydrochloride<br>* intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off<br>|
| No Intervention: group-S<br>At the end of surgery and immediately after the inhalational agent was discontinued, 2 mL of normal saline was administered intramuscularly. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agitation, Emergence, Ketamine, Intramuscular, Nasal surgery