Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial

bronchoscopy - a randomized controlled trial" (EudraCT number: 2015-005274-38, protocol number: "BRONSE") is a phase IV single centre prospective randomized controlled trial with parallel groups. A total of 150 adult outpatients undergo diagnostic bronchoscopy during sedation and are randomized into three sedation arms (1:1:1); sedation with midazolam and morphine-scopolamine as premedication (clinical routine), sedation with propofol using PCS and morphine-scopolamine as premedication, and sedation with propofol using PCS and glycopyrronium bromide as premedication. The study is partially blinded, the bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms). The hypothesis is that PCS increase the amount of patients ready for discharge, and further that patient characteristics affect the amount of propofol administered. The endpoints are primarily the amount of patients ready for discharge within 2 hours and secondary assessment of patient recovery and satisfaction as well as bronchoscopist evaluation and doses of administrated drugs. Finally safety variables are collected such as vital signs and interventions performed to maintain cardiovascular and respiratory stability.

Study Overview

• Status: Completed
• Conditions: Sedation, Bronchoscopy
• Intervention / Treatment: Drug: Midazolam; Drug: morphine-scopolamine; Drug: Propofol-Lipuro; Drug: Glycopyrrolate

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patient (≥18 years)
• Planned bronchoscopic procedure with sedation in an outpatient setting
• The patient have after receiving information about the study given his/her signed informed consent to participate.
• Women of childbearing potential only if use of effective contraceptive.

Exclusion Criteria:

• Positive pregnancy test S-β-HCG.
• Known/suspected allergy or contraindication* to any medication within the study.
• Functional disability in both hands which affect the possibility to operate the PCS device.
• Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Midazolam and morphine-scopolamine; Sedation during bronchoscopy with midazolam and morphine-scopolamine as premedication.	Drug: Midazolam; Midazolam is givenas sedation to the Control arm.; Drug: morphine-scopolamine; Given as premedication for the Control arm and one of the interventions arms.
Experimental: PCS (propofol) with morphine-scopolamine; Sedation during bronchoscopy with propofol using PCS and morphine-scopolamine as premedication	Drug: morphine-scopolamine; Given as premedication for the Control arm and one of the interventions arms.; Drug: Propofol-Lipuro; Propofol is given as sedation to both intervention arms.
Experimental: PCS (propofol) with glycopyrronium bromide; Sedation during bronchoscopy with propofol using PCS and glycopyrronium bromide as premedication.	Drug: Propofol-Lipuro; Propofol is given as sedation to both intervention arms.; Drug: Glycopyrrolate; Given as premedication for one of the intervention arms..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge Assessment Using PADSS After 2 Hours Number of Patients Reaching PADSS Score 10 After 2 Hours	Post Anaesthetic Discharge Scoring System (PADSS).A measurement of the PADSS score is done by pulmonary nurse every 15 min after bronchoscopy is finished (when bronchoscope is removed) for 2 hours. The PADSS is used to clinically assess if the patient is ready to be discharged after anaesthesia/sedation and consist of five criteria: vital signs, ambulation, nausea and/or vomiting, pain and surgical bleeding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a total score of 10 are considered ready for discharge after 2 hours.	2 hours after bronchoscopy is finished

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Self-rated Patient Questionaries' Using S-PSR	Post-discharge Surgical Recovery Scale (S-PSR) The modified Swedish version S-PSR is based on the "Post-discharge Surgical Recovery Scale" and is a 14-item questionnaire to assess the recovery post-discharge regarding the patients' health status and activity (see further appendix 2). Each item is rated using a semantic differential scale and the total sum is multiplied by 100. The possible range is 10-100, with higher score indicating a more favourable postoperative recovery.	The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the evening on the day of bronchoscopy. It takes approximately 2 minutes to complete the questionnaire.
Quality of Recovery (QoR-23)	Modified version of Quality of Recovery (QoR-23) Minimum value 23. Maximum value 115. A higher score indicate a better quality of recovery. The questionnaire "Quality of Recovery" (QoR-23) is a 23 item questionnaire to assess recovery after day surgery regarding the patients' emotional state, physical comfort and physical independence (see further appendix 4). Each item is rated on a five-point scale (1-5) and the scores are summed.	The assessment is done by the patient at home (or at ward if pro-longed hospital stay is necessary) in the morning the day after bronchoscopy. It takes less than 1 minute to complete the assessment.
Patients' Satisfaction Using a Likert-type Scale	overall satisfaction with the procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied). The patient may comment any cause which made the satisfaction score high or low and if the patient would like to receive the same method of sedation during a future bronchoscopy.	After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours.
Bronchoscopist Evaluation Using a Likert-type Scale	the bronchoscopist assess their perception of cough, bronchial secretion respectively circumstances for a smooth performance of the bronchoscopy of procedure using the Likert-type scale (1. Very dissatisfied, 2. Dissatisfied, 3. Neither satisfied nor dissatisfied, 4. Satisfied, 5. Very satisfied).	Directly after completion of the procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Sedation Using the Observer's Assessment of Alertness/Sedation (OAA/S) Scale	Level of sedation is assessed every 5th minute during the procedure by the nurse anaesthetist using The Observer's Assessment of Alertness/Sedation (OAA/S) scale whereby a higher score represent a lighter sedation. Below is the scale descriped, Observation/score: Responds readily to name spoken in normal tone/5 Lethargic response to name spoken in normal tone/4 Responds only after name is called loudly and/or repeatedly/3 Responds only after mild prodding or shaking/2 Does not respond to mild prodding or shaking/1	Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.
Number of Participants With Interventions Performed	Number of participants with interventions performed to maintain cardiovascular (if atropine or ephidrine has been given) and respiratory stability (if assisted ventilation, chin lift or painful stimulation has been performed). Assesed every five minutes during the procedure.	From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes.
Arterial Oxygen Saturation (SpO2)		Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.
Respiratory Rate Per Minute (RR)		Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.
Non-invasive Blood Pressure (mmHg)		Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.
Heart Rate (Beats Per Minute, HR).		Every five minutes during the procedure (from procedure start until end of procedure (extraction of bronchoscope), , estimated period of time 0-60 minutes, and thereafter after the procedure every 15 minutes until PADSS score ≥9 or maximum 4 hours.

Collaborators and Investigators

• Sponsor: Lena Nilsson

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2016
• Primary Completion (Actual): May 9, 2017
• Study Completion (Actual): May 9, 2017

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 31, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Mydriatics; Midazolam; Propofol; Morphine; Glycopyrrolate; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: BRONSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No