Intramuscular Ketamine Effect on Postnasal Surgery Agitation

J

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

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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