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Effectiveness of Ketamine nebulisation in reducing sore throat following surgery under General Anesthesia

Effectiveness of nebulised Ketamine on the incidence and severity of post-operative sore throat in patients undergoing general anesthesia with tracheal intubation: a Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2017/015
Enrollment
Unknown
Registered
2017-06-09
Start date
2017-06-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Post-operative sore throat

Interventions

The study will be conducted at the Department of Anesthesiology, Azeezia Medical College Hospital, Kerala, India. Consenting participants meeting the inclusion/exclusion criteria will be randomized i

Sponsors

Department of Anesthesiology Azeezia Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients of American Society of Anaesthesiologists (ASA) physical status 1-2 2. Aged between 18-60 years 3. Undergoing general anesthesia with tracheal intubation, of duration up to 2 hours.

Exclusion criteria

Exclusion criteria: 1. A history of pre-operative sore throat 2. Oral and nasal surgeries 3. Upper respiratory tract infection 4. Chronic obstructive pulmonary disease 5. Head and neck surgeries 6. Pregnant females 7. Mallampati grade >2 8. Known allergies to study drug 9. Those who required more than one attempt at intubation

Design outcomes

Primary

MeasureTime frame
Effectiveness of nebulised ketamine in reducing post-operative sore throat in adult patients undergoing GA of duration of up to 2 hour. [Assessment will be done at 0,2,4,6,12 and 24 h after extubation.] Incidence and severity of post-operative sore-throat in patients after GA Tools used to measure will be a 4 point scale: 0 - No sore throat even on asking 1 - Mild sore throat (complaints of sore throat only on asking) 2 - Moderate sore throat (complains of sore throat his/her own) 3 - Severe sore throat (complaints of throat pain,hoarseness of voice and in obvious distress) [Assessment will be done at 0,2,4,6,12 and 24 h after extubation.]

Secondary

MeasureTime frame
Side-effects 1.1. Nausea and vomiting 1.2. Cough 1.3. Dry mouth 1.4. Hallucination 1.5. Respiratory depression 1.6. Hemodynamic instability Tools used to measure will be: Post-op nausea and vomiting will be graded on a four-point ordinal scale (0 = no nausea, 1 = mild nausea, 2 = moderate nausea, 3 = severe nausea with vomiting) Cough: 0 – No cough at any time since operation 1 – Minimal cough 2 – Moderate cough 3 - Severe cough Dry mouth: 1. No disability 2. Dryness requiring additional fluids for swallowing 3. Dryness causing dietary alterations,interference with sleep,speaking Hallucination: Very mild: While resting or going to sleep, sees visions, smells odours, or hears voices Mild: While in a clear state of consciousness, hears a voice calling the subject’s name, experiences non-verbal auditory hallucinations (e.g., sounds or whispers), formless visual hallucinations Moderate: Occasional verbal, visual, gustatory, olfactory, or tactile hallucinations with no functional impairment Moderately Severe: Experiences daily hallucinations OR some areas of functioning are disrupted by hallucinations. Severe: Experiences verbal or visual hallucinations several times a day Extremely Severe: Persistent verbal or visual hallucinations throughout the day Respiratory depression: Key clinical signs include 1. Respiratory rate less than 8 breaths/minute 2. SpO2 less than 90% in the absence of abnormal baseline SpO2 3.Cardio pulmonary arrest. Hemodynamic instability: Key signs and symptoms include 1. Hypotension (A blood pressure 140/90 mmHg or a MAP >105 mm Hg ) 2. Abnormal heart rate 3. Decreased urine output 4. Altered consciousness [Side effects will be assessed 8 hourly in the first 24 hours after extubation]

Countries

India

Contacts

Public ContactDr. Derlin Thomas

Assistant Professor

derlin.t@gmail.com09447768944

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026