Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University Hospital, Basel, Switzerland.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Basel, Switzerland
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01081002
First received: March 2, 2010
Last updated: March 4, 2010
Last verified: March 2010
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Purpose
It is unclear whether a topical pharyngeal anesthesia adds any benefit to the upper gastrointestinal endoscopy under a propofol sedation. We hypothesize that a topical pharyngeal anesthesia does not ease the upper gastrointestinal endoscopy under propofol sedation. The aim of this study is therefore to quantify the impact of a topical pharyngeal anesthesia to the upper gastrointestinal endoscopy in patients sedated with propofol.
Patients will be randomized to receive a topical pharyngeal spray containing either an anesthetic drug (lidocaine 10%) or a placebo. Thereafter the upper endoscopy will be conducted in its standard manner.
| Condition | Intervention | Phase |
|---|---|---|
|
Conscious Sedation |
Drug: Lidocaine 10% Drug: Diluted gentian root solution |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Study of Propofol Sedation During Upper Endoscopy With and Without Topical Pharyngeal Anesthesia |
Resource links provided by NLM:
Further study details as provided by University Hospital, Basel, Switzerland:
Primary Outcome Measures:
- Number triggered gag reflex during the intubation of the endoscope [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ] [ Designated as safety issue: No ]
- Number of attempts of intubation with the endoscope through the upper esophageal sphincter [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ] [ Designated as safety issue: No ]
- Extent of salivation during intubation [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Amount of propofol used to successfully intubate the esophagus [ Time Frame: Start of the exam until the successful intubation of the esophagus with the endoscope ] [ Designated as safety issue: No ]
- Total amount of propofol used during the investigation [ Time Frame: From the start until the end of the exam ] [ Designated as safety issue: No ]
- Overall assessment of the procedure by the endoscopist [ Time Frame: Immediately after finishing the endoscopy ] [ Designated as safety issue: No ]
- Assumption of the endoscopist if lidocaine or placebo has been used [ Time Frame: Immediately after finishing the endoscopy ] [ Designated as safety issue: No ]
- Overall assessment of the investigation by the patient [ Time Frame: Immediately after recovery of consciousness of the patient ] [ Designated as safety issue: No ]
- Extent of amnesia in the patient [ Time Frame: Immediately after recovery of consciousness of the patient ] [ Designated as safety issue: No ]
- Experienced problems (aspiration, bronchospasm, desaturation) [ Time Frame: From the start until the end of the exam ] [ Designated as safety issue: Yes ]
- The impact of the individual endoscopists or registered nurses involved in the endoscopy [ Time Frame: After finishing the entire study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Anesthesia with lidocaine 10%
3 min before sedation 4 puffs of terbutaline diluted lidocaine solution (Xylocaine ® 10% spray, Astra Zeneca, London, UK) will be sprayed on the pharynx
|
Drug: Lidocaine 10%
3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
Other Name: Xylocaine 10% spray
|
|
Placebo Comparator: Anesthesia with gentian root solution
3 min before sedation 4 puffs of highly diluted gentian solution will be sprayed on the pharynx
|
Drug: Diluted gentian root solution
As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia
Other Name: Gentian root extract, CAS no. 72968-42-4
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Scheduled diagnostic upper endoscopy
- Wish to be sedated
- ASA class I - III
- Signed informed consent
Exclusion Criteria:
- Emergency medical examinations
- Therapeutic Endoscopy
- ASA class IV
- Pregnancy
- Known allergy to propofol or lidocaine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081002
Contacts
| Contact: Ludwig Heuss, MD | +41 44 397 20 12 | ludwig.heuss@spitalzollikerberg.ch |
| Contact: Lukas Degen, Prof | +41 61 265 51 74 | lukas.degen@unibas.ch |
Locations
| Switzerland | |
| University Hospital; Division of Gastroenterology and Hepatology | Recruiting |
| Basel, BS, Switzerland, 4031 | |
| Contact: Lukas Degen, Prof +41 61 265 51 74 lukas.degen@unibas.ch | |
| Principal Investigator: Lukas Degen, Prof | |
| Sub-Investigator: Michael Manz, MD | |
| Hospital of Zollikerberg, Internal Medicine | Recruiting |
| Zollikerberg, ZH, Switzerland, 8125 | |
| Contact: Ludwig Heuss, MD +41 44 397 20 12 ludwig.heuss@spitalzollikerberg.ch | |
| Principal Investigator: Ludwig Heuss, MD | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
| Principal Investigator: | Ludwig T Heuss, MD | Spital Zollikerberg |
| Principal Investigator: | Lukas Degen, Prof | University Hospital, Basel, Switzerland |
More Information
No publications provided by University Hospital, Basel, Switzerland
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lukas Degen, Prof, University Hospital Basel, Division of Gastroenterology and Hepatology, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01081002 History of Changes |
| Other Study ID Numbers: | EKBB 101/09 |
| Study First Received: | March 2, 2010 |
| Last Updated: | March 4, 2010 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital, Basel, Switzerland:
|
Propofol Conscious sedation Topical pharyngeal anesthesia Anesthetics, Local Gastrointestinal Endoscopy |
Additional relevant MeSH terms:
|
Anesthetics Lidocaine Propofol Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 21, 2013