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Intramuscular Ketamine Effect on Postnasal Surgery Agitation

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05313659
Enrollment
193
Registered
2022-04-06
Start date
2022-05-11
Completion date
2022-10-20
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation, Emergence

Keywords

Agitation, Emergence, Ketamine, Intramuscular, Nasal surgery

Brief 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.

Interventions

DRUGKetamine Hydrochloride

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

Sponsors

Jordanian Royal Medical Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development of Agitationimmediately 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.

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026