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出境医 / 临床实验 / Conscious Sedation for Outpatient Colonoscopy

Conscious Sedation for Outpatient Colonoscopy

Study Description
Brief Summary:
Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.

Condition or disease Intervention/treatment Phase
Conscious Sedation Drug: Dexmedetomidine Drug: Propofol Drug: Remifentanil Phase 2

Detailed Description:
Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification.
Primary Purpose: Other
Official Title: Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
Actual Study Start Date : June 15, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : January 5, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: (Dexmedetomidine)Dex group
The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure
 Drug: Dexmedetomidine
dexmedetomidine sedation
Other Name: dexmedetomidine infusion
Active Comparator: Propofol-Remifentanil (P-R) group
Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.
 Drug: Propofol
propofol sedation
Other Name: propofol infusion

Drug: Remifentanil
Remifentanil sedation
Other Name: Remifentanil infusion
Outcome Measures
Primary Outcome Measures :
  1. Sedation [ Time Frame: Perioperative ]
    Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.


Secondary Outcome Measures :
  1. Mean arterial blood pressure [ Time Frame: Perioperative ]
    Mean arterial blood pressure in mmHg

  2. Heart rate [ Time Frame: Perioperative ]
    Heart rate in beats/minutes

  3. Oxygen saturation [ Time Frame: Perioperative ]
    Arterial oxygen saturation as a percentage of the total haemoglobin.

  4. Hypotension [ Time Frame: Perioperative ]
    Number of patients with hypotension

  5. Bradycardia [ Time Frame: Perioperative ]
    Number of patients with bradycardia

  6. Analgesia [ Time Frame: Perioperative ]
    Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I or II physical status
  • 18-65 years
  • Scheduled for elective colonoscopy

Exclusion Criteria:

  • History of allergy to any of the study drugs
  • Alcohol or drug abuse.
  • Second and third-degree heart block.
  • Morbid obesity.
  • Pregnant and lactating women.
  • Psychiatric disorders.
  • Severe cardiac, respiratory, renal, and liver diseases
Contacts and Locations

Locations
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Egypt
Faculty of Medicine
Cairo, Shebin El-kom, Egypt, 32511
Sponsors and Collaborators
Menoufia University
Investigators
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Principal Investigator: Abd-Elazeem A Elbakry, MD Associate professor
Tracking Information
First Submitted Date  ICMJE April 21, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE June 15, 2019
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2019) 		Sedation [ Time Frame: Perioperative ]
Degree of sedation by Ramsay sedation score from 1 inadequate sedation to 6 excessive sedation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2019)
  • Mean arterial blood pressure [ Time Frame: Perioperative ]
    Mean arterial blood pressure in mmHg
  • Heart rate [ Time Frame: Perioperative ]
    Heart rate in beats/minutes
  • Oxygen saturation [ Time Frame: Perioperative ]
    Arterial oxygen saturation as a percentage of the total haemoglobin.
  • Hypotension [ Time Frame: Perioperative ]
    Number of patients with hypotension
  • Bradycardia [ Time Frame: Perioperative ]
    Number of patients with bradycardia
  • Analgesia [ Time Frame: Perioperative ]
    Measured by visual analogue scale [from 0 "no pain" to 10 "worst imaginable pain"]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conscious Sedation for Outpatient Colonoscopy
Official Title  ICMJE Dexmedetomidine Versus Propofol-Remifentanil Conscious Sedation for Outpatient Colonoscopy: A Prospective Randomized Double-blind Trial.
Brief Summary Although colonoscopy is a mildly painful procedure, the pain and the procedure itself are distressful for most patients. This raises the attention for using different sedation regimens aiming at maintaining optimal sedation level with maintained airway and stable haemodynamics all through the procedure. The present study was scheduled to investigate the sedative efficacy of dexmedetomedine versus propofol-remifentanil for outpatient colonoscopy.
Detailed Description Eighty patients undergoing outpatient colonoscopy will be randomized into two equal groups. In Dexmedetomidine (DEX) group the patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure. In the PR group, propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min. If the patient complained of pain or discomfort, the infusion rates of dexmedetomidine (DEX group) or propofol-remifentanil (P-R group) will be increased. If the higher limit of the dose range of the study drugs reached, additional fentanyl 0.5 μg/kg i.v. boluses will be administered. Rescue medication consisting of propofol boluses of 0.5 mg/kg i.v. will be given if the previous protocol failed. Sedation score,haemodynamics, end-tidal carbon dioxide, oxygen saturation, total fentanyl, propofol bolus doses, patient and colonoscopist satisfaction and side effects will be recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
A blinded investigator that was not involved in the anaesthetic management of the patients, collected the intra-operative and postoperative data. The patients and colonoscopist were blinded to group allocation. For blinding purposes, two drug infusion pumps were used in every patient where the infusion pumps and i.v. connection lines were concealed to avoid identification.
Primary Purpose: Other
Condition  ICMJE Conscious Sedation
Intervention  ICMJE
  • Drug: Dexmedetomidine
    dexmedetomidine sedation
    Other Name: dexmedetomidine infusion
  • Drug: Propofol
    propofol sedation
    Other Name: propofol infusion
  • Drug: Remifentanil
    Remifentanil sedation
    Other Name: Remifentanil infusion
Study Arms  ICMJE
  • Active Comparator: (Dexmedetomidine)Dex group
    The patients will be administered a loading dose of i.v. dexmedetomidine 1 μg/kg over 10 min, followed by a continuous infusion of 0.2-1 μg/kg/h, titrated according to the sedation score, till the end of the procedure
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Propofol-Remifentanil (P-R) group
    Propofol will be started by a loading dose of 0.5 mg/kg over 3-5 minutes then a maintenance infusion of 25-75 μg kg/min. Remifentanil infusion will be started at 1 μg kg over one minute then and 0.01-0.1 μg kg/min.
    Interventions:
    • Drug: Propofol
    • Drug: Remifentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 5, 2021
Actual Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I or II physical status
  • 18-65 years
  • Scheduled for elective colonoscopy

Exclusion Criteria:

  • History of allergy to any of the study drugs
  • Alcohol or drug abuse.
  • Second and third-degree heart block.
  • Morbid obesity.
  • Pregnant and lactating women.
  • Psychiatric disorders.
  • Severe cardiac, respiratory, renal, and liver diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03925779
Other Study ID Numbers  ICMJE 2019/3/15/9
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
Study Sponsor  ICMJE Menoufia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abd-Elazeem A Elbakry, MD Associate professor
PRS Account Menoufia University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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