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Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

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ClinicalTrials.gov Identifier: NCT03357393
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Lena Nilsson, University Hospital, Linkoeping

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sedation, Bronchoscopy Drug: Midazolam Drug: Propofol-Lipuro Drug: morphine-scopolamine Drug: Glycopyrrolate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: The bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms).
Primary Purpose: Treatment
Official Title: Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy - a Randomized Controlled Trial
Actual Study Start Date : April 4, 2016
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : May 9, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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: Propofol-Lipuro
Propofol is given as sedation to both intervention arms.

Drug: morphine-scopolamine
Given as premedication for the Control arm and one of the interventions 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..




Primary Outcome Measures :
  1. Discharge assessment using PADSS after 2 hours [ Time Frame: 2 hours after bronchoscopy is finished ]
    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.


Secondary Outcome Measures :
  1. Assessment of self-rated patient questionaries' using S-PSR [ Time Frame: 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. ]
    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.

  2. Assessment of self-rated patient questionaries' using QoR-23 [ Time Frame: 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. ]
    Modified version of Quality of Recovery (QoR-23) 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. A higher score indicate a better quality of recover

  3. Patients' satisfaction using a Likert-type scale [ Time Frame: After patient has recovered after bronchoscopy and before discharge home, estimated period of time 0-24 hours. ]
    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.

  4. Bronchoscopist evaluation using a Likert-type scale [ Time Frame: Directly after completion of the procedure. ]
    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).

  5. Total dose given of topical anaesthetic, analgesia and sedation [ Time Frame: During procedure. ]
    The total dose of given medication of topical anaesthetic, analgesia and sedation will be registered for each patient.


Other Outcome Measures:
  1. Level of sedation using the Observer's Assessment of Alertness/Sedation (OAA/S) scale [ Time Frame: Assessement are done every 5th minute from procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. ]

    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


  2. Interventions [ Time Frame: From procedure start until end of procedure (extraction of bronchoscope), estimated period of time 0-60 minutes. ]
    Number of 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.

  3. Arterial oxygen saturation (SpO2) [ Time Frame: 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. ]
  4. Respiratory rate per minute (RR) [ Time Frame: 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. ]
  5. Non-invasive blood pressure (mmHg) [ Time Frame: 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. ]
  6. Heart rate (beats per minute, HR). [ Time Frame: 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Lena Nilsson, Principal Investigator, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT03357393     History of Changes
Other Study ID Numbers: BRONSE
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glycopyrrolate
Midazolam
Scopolamine
Morphine
Propofol
Butylscopolammonium Bromide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antiemetics
Autonomic Agents