Examining the effect of a calming nasal spray (ketamine) in reducing nausea and creating relaxation in patients undergoing "flexible bronchoscopy".

Evaluation of Intranasal Ketamine for Sedation and Reflex Suppression in Patients Undergoing Flexible Fiberoptic Bronchoscopy: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250923067343N2

Enrollment

102

Registered

2026-02-14

Start date

2026-02-08

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Patients undergoing bronchoscopy. ????? ???? ????? ????? ???? ?? ????? ???? ????. ???????? ?? ?? ????? ?????? ???? ??????????? ??????

Interventions

Intervention group:.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria:· Age 18–65 years.· ASA (American Society of Anesthesiologists) physical status class I or II.· Requiring flexible fiberoptic bronchoscopy.· Providing written informed consent for the procedure.

Exclusion criteria

Exclusion criteria: Allergy or contraindication to ketamine or drugs in the control group.· Severe psychiatric illness (active psychosis).· Heart failure or uncontrolled hypertension.· Oxygen saturation <90% at baseline.· Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Severity of Gag Reflex: · Type: Ordinal quantitative (rating scale). Timepoint: Recording Method: Assessment is performed and recorded at the moment of bronchoscope passage through the pharynx by the bronchoscopist and confirmed by the anesthesia nurse. Method of measurement: Severity of Gag Reflex: · Type: Ordinal quantitative (rating scale). · Scale: 1 to 5 Likert scale. · Definition of Grades: · 1 (None): Passage with no issue. · 2 (Mild): Minor, transient contraction. · 3 (Moderate): Clear contraction, requiring a brief pause. · 4 (Severe): Strong, repeated contraction, hindering the procedure. · 5 (Very Severe): Intolerable, requiring procedure cessation.	—

Measure

Time frame

Severity of Gag Reflex: · Type: Ordinal quantitative (rating scale). Timepoint: Recording Method: Assessment is performed and recorded at the moment of bronchoscope passage through the pharynx by the bronchoscopist and confirmed by the anesthesia nurse. Method of measurement: Severity of Gag Reflex: · Type: Ordinal quantitative (rating scale). · Scale: 1 to 5 Likert scale. · Definition of Grades: · 1 (None): Passage with no issue. · 2 (Mild): Minor, transient contraction. · 3 (Moderate): Clear contraction, requiring a brief pause. · 4 (Severe): Strong, repeated contraction, hindering the procedure. · 5 (Very Severe): Intolerable, requiring procedure cessation.

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Secondary

Measure	Time frame
Sedation Quality: Level of consciousness and responsiveness. Timepoint: During procedure. Method of measurement: MOAA/S (Modified Observer's Assessment of Alertness/Sedation).;Patient Satisfaction Patient's subjective satisfaction with the experience. Timepoint: 30minutes after procedure completion in recovery. Method of measurement: Numeric Rating Scale (0-10).;Physician Satisfaction Bronchoscopist's satisfaction with procedural. Timepoint: conditions Immediately after bronchoscopy completion. Method of measurement: Numeric Rating Scale (0-10).	—

Measure

Time frame

Sedation Quality: Level of consciousness and responsiveness. Timepoint: During procedure. Method of measurement: MOAA/S (Modified Observer's Assessment of Alertness/Sedation).;Patient Satisfaction Patient's subjective satisfaction with the experience. Timepoint: 30minutes after procedure completion in recovery. Method of measurement: Numeric Rating Scale (0-10).;Physician Satisfaction Bronchoscopist's satisfaction with procedural. Timepoint: conditions Immediately after bronchoscopy completion. Method of measurement: Numeric Rating Scale (0-10).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactKobra Rafiei Badi

Shahid Beheshti University of Medical Sciences

abrisham57@gmail.com+98 21 2712 3888

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026