Intramuscular Ketamine Effect on Postnasal Surgery Agitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-10-20

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.

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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.

Conditions

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Agitation, Emergence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group-K

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

Group Type EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type DRUG

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

group-S

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ketamine Hydrochloride

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes