A Prospective, Randomized, Double Blind Study to compare safety and comfort of Midazolam vs. Fentanyl administration during Diagnostic flexibile bronchoscopy

AIM & OBJECTIVES

1.To study and compare the safety and comfort of midazolam and fentanyl during flexible bronchoscopy under sedation.

2.Questionarie of the patient and bronchoscopist will be analysed.

MATERIALS****AND METHODS

STUDY SITE: ACS MEDICAL COLLEGE AND HOSPITALS, DEPARTMENT OF RESPIRATORY MEDICINE.

STUDY DESIGN: RANDOMIZED CONTROL TRIAL – DOUBLE BLINDED, TWO ARM, EQUIVALENCE TRIAL.

PROCEDURE:

1.Before beginning the procedure, the vital parameters such as pulse rate, blood pressure, respiratory rate, and SpO2 levels will be noted, and continuous monitoring initiated.

2.Participants under study shall undergo computer-generated block randomization with variable block sizes. The respective randomization lists shall be kept in sealed, opaque envelopes for allocation concealment.

3. A member of the bronchoscopy team not involved in the study shall prepare the study drug after picking randomization slip and inject the study drugs away from the vision of the investigators (who shall be blinded to the sedation given).

4.For participants randomized to Arm 1- midazolam 1-2 mg IV (0.035 mg/kg) and for participants randomized to Arm 2 - fentanyl 25- 50 mcg IV (0.5 mcg/Kg) will be given.

5.Two ml of 2% lignocaine jelly will be administered into one of the patent nostrils of the patient.

6.After an additional waiting period of 2 min, the bronchoscope is passed through the patent nostril and then the throat. Two ml of 2% lignocaine spray will be sprayed at the throat and additional 2 ml at vocal cords, by spray as you go technique.

7.The bronchoscope is advanced below the vocal cords and stationed at the level of carina, where 1 ml 2% lignocaine is sprayed.

8.If the Ramsay Sedation Scale (RSS) was 1 at any time after the lignocaine application was completed, the rescue medication in the form of Injection Midazolam 0.5 mg IV  will be administered in a stepwise manner, with a 2 min gap between doses.

7.The bronchoscope is advanced beyond carina where 1 ml of 2% lignocaine is sprayed into each main bronchus, the bronchoscope was advanced into either bronchus to evaluate the bronchial tree, and the sampling procedure for which the patient was scheduled is completed.

8.Vital parameters such as pulse rate, blood pressure, respiratory rate, and SpO2 levels will be recorded at 5 min interval from time zero – i.e., from insertion of bronchoscope.

9.Lidocaine dosage, completeness of the procedure, complications if any, and total duration of procedure will be noted.

10.Vital parameters will be recorded 10 min after completion of the procedure.

11.Six hours after completion of flexible bronchoscopy, a questionnaire – adapted from an earlier study – provided to the patients. This assess patient’s tolerance of the procedure and their satisfaction level.

12. Primary and secondary outcomes will be assed.

Ethical guidelines for biomedical research on human subjects (as perICMR) will be followed.Subjects will be enrolled only after obtaining informed consent and assent. Privacy & confidentiality ofsubjects will be maintained.