Comparison between Midazolam and Dexmedetomidine in bronchoscopy

Recruiting

Conditions: All patients in the age group 18 to 65 years requiring flexible bronchoscopy in the Department of Respiratory Medicine.

Registration Number: CTRI/2017/10/009969

Lead Sponsor: Kasturba Medical College Manipal

Brief Summary: **AIM** To study the effects of intravenous Midazolam and intravenous Dexmedetomidine on patient response to flexible bronchoscopy.

**OBJECTIVES**To assess patient response and comfort in flexible bronchoscopy,To attenuate the pressor response in flexible bronchoscopy

**METHODOLOGY**

The enrolled patients undergoing FB will be randomized into two groups, Group **A**: Midazolam group and Group **B**: Dexmedetomidine group, after getting an informed written consent in the language they understand. Randomization will be done by Block Randomization (chit method). A total of 9 envelopes will be created and 27 chits will be made, with each bearing the letters M and D (corresponding to Midazolam and Dexmedetomidine respectively) arranged in one of the two possible sequences MD or DM. Three chits will be placed in each of the 9 envelopes. Nine such sets will be prepared. The envelopes will be opened one by one. Chits will be picked up and cases are allocated to each group as per the letter sequence

Patients will be monitored for Pulse Rate (PR), Non-InvasiveBlood Pressure (NIBP), Respiratory Rate (RR), Oxygen Saturation (SPO2), and Ramsay Sedation Score (RSS) for sedation status**11**. After recording the baseline from these parameters, an intravenous line will be established in one of the upper limb.

To ensure double blinding, before the procedure the study drugs will be prepared in two syringes labeled as **1** and **2**.

**Syringe 1**will contain either Dexmedetomidine **0.5 Âµg/kg** (rounded off to the nearest decimal) diluted in normal saline to make up to 10ml or 10ml of Normal saline which will be infused over 10 minutes starting from time 0 till 10thminute.Ten ml syringe will be used.

**Syringe 2**will contain either Midazolam **0.035 mg/kg** diluted to 4ml with Normal Saline or 4 ml of Normal saline which will be given at the beginning of 9th minute. Five ml syringe will be used

The study will begin with infusion of contents of syringe **1** slowly over 10 minutes. At the beginning of 9th minute, contents of syringe **2** will be injected. At the end of 10th minute bronchoscopy will commence.

Two ml of 2 % lignocaine jelly will be administered into one of the patent nostrils of the patient. 2 ml of 2 % lignocaine spray will be sprayed at the oropharynx and 2 ml at vocal cords. After a minute, the bronchoscope will be passed below the vocal cords and 1 ml of 2% lignocaine is sprayed over trachea. At the level of carina, 1ml of 2 % lignocaine will be sprayed. The bronchoscope will be passed beyond carina and 1 ml of 2 % lignocaine will be sprayed into each main bronchus. After cough subsides, the bronchoscope will be advanced into either bronchi to examine the bronchial tree and the sampling procedure for which the patient is planned will be completed. Additional 2% lignocaine spray will be sprayed if the patient develops recurrent cough.

Rescue medication in the form of intravenous Midazolam **0.5mg** bolus will be administered with a gap of at least 2minutes between the doses. It will be kept as an open labelled syringe.

The study involves three different observers

**Observer A:**The person, who picks up the randomization slip, prepares the study drug ensuring blinding (labels the syringes 1 and 2). Observer A will not be involved in the further study.

**Observer B:** The person, who performs the bronchoscopy, will not be aware of contents of syringe 1 and 2.

**Observer C:** The person, who assess the patients, explains study methodology, takes consent, administer the study drugs and records the study parameters. This person will not be aware of contents of syringe 1 and 2.

Both observers **B** and **C** will be blinded to the study drug.

**Evaluation**The patient comfort to bronchoscopy will be assessed both subjectively and objectively

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 54

Inclusion Criteria

All patients in the age group 18 to 65 years requiring flexible bronchoscopy in the Department of Respiratory Medicine.

Exclusion Criteria

1.Patients with known or suspected allergy to Midazolam or Dexmedetomidine 2.Patients with renal or hepatic insufficiency 3.Patients with seizure disorder 4.COPD patients with FEV1 <50% 5.Patients with psychiatric disorder 6.Haemodynamically unstable patients including cardiac failure 7.Heart rate <50 beats per min or second or third degree heart block 8.Patients with body weight more than 70kg.
9.Pregnancy and lactation 10.Hypovolemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Composite score during the bronchoscopy procedure.	Prior, during, 10mins after bronchoscopy and 24hours after bronchoscopy
2.Numerical Rating Scale (NRS)for pain intensity and distress.	Prior, during, 10mins after bronchoscopy and 24hours after bronchoscopy
3.Visual Analogue Scale for cough.	Prior, during, 10mins after bronchoscopy and 24hours after bronchoscopy
5.Ramsay sedation score.	Prior, during, 10mins after bronchoscopy and 24hours after bronchoscopy
4.Ease of bronchoscopy procedure.	Prior, during, 10mins after bronchoscopy and 24hours after bronchoscopy
6.Post- procedure patient response after 24hours.	Prior, during, 10mins after bronchoscopy and 24hours after bronchoscopy

Secondary Outcome Measures

Name	Time	Method
1.Duration of bronchoscopy procedure.	2.Number of doses of rescue medication required during the procedure.

Trial Locations

Locations (1): Kasturba Medical College Manipal
🇮🇳
Udupi, KARNATAKA, India
Kasturba Medical College Manipal
🇮🇳Udupi, KARNATAKA, India
DR SRI SHIVARAJ KUMAR
Principal investigator
9663531697
srishivarajkumar@gmail.com