Skip to content

Effect of ketamine administered into the trachea on sore throat after spinal surgery under general anesthesia

The effect of endotracheal administration of ketamine on sore throat after spinal surgery in patients under general anesthesia with endotracheal intubation: A randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241214064051N4
Enrollment
34
Registered
2025-05-12
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Postoperative sore throat following general anesthesia with endotracheal intubation. Pain in throat

Interventions

Intervention 1: Intervention group: The intervention group will receive 2 mL of ketamine with a concentration of 5 mg/mL, administered into the endotracheal tube immediately before intubation, as a si

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Age between 20 and 60 years ASA physical status class I or II Candidates for elective spinal surgery in the prone position Under general anesthesia with endotracheal intubation Signed written informed consent

Exclusion criteria

Exclusion criteria: History of sore throat before surgery Patients with asthma or COPD Smokers Recent use of NSAIDs Patient unwilling to participate in the study Known allergy to ketamine or normal saline Mallampati score greater than 2 More than one attempt required for endotracheal intubation Intubation time exceeding 20 seconds

Design outcomes

Primary

MeasureTime frame
The primary outcome variable is the incidence of postoperative sore throat. It is measured using a 4-point severity scale at 1, 6, 24, 36, 48, 60, and 72 hours after extubation. The sample size was calculated based on expected differences in the incidence of sore throat between the ketamine and placebo groups. Timepoint: 1, 6, 24, 36, 48, 60, and 72 hours after extubation. Method of measurement: Sore throat will be measured using a standardized 4-point verbal rating scale, where 0 = no pain, 1 = mild, 2 = moderate, and 3 = severe.

Secondary

MeasureTime frame
Severity of postoperative sore throat will be evaluated using a 4-point verbal rating scale to assess the impact of intervention on pain intensity. Timepoint: 1, 6, 24, 36, 48, 60, and 72 hours after extubation. Method of measurement: 4-point verbal rating scale (0 = no pain, 1 = mild, 2 = moderate, 3 = severe).;Time of onset of postoperative sore throat will be recorded in hours after extubation, based on patient self-report, to evaluate the delay in symptom appearance due to the intervention. Timepoint: Continuously assessed within the first 72 hours after extubation. Method of measurement: Patient self-report recorded via a structured questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Khoshnevis

Babol University of Medical Sciences

maryamkhoshnevis8@gmail.com+98 911 218 2557

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026