Intramuscular Ketamine Effect on Postnasal Surgery Agitation

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.

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Key information

Conditions

Agitation, Emergence Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Confusion Delirium Dyskinesias Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jordanian Royal Medical Services

Amman, 11855, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hydrochloride

Drug

intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off

Primary outcomes

Development of Agitation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jordanian Royal Medical Services

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 6, 2022
Registry last updated: Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed