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Trial registered on ANZCTR


Registration number
ACTRN12615000369527
Ethics application status
Approved
Date submitted
23/01/2015
Date registered
22/04/2015
Date last updated
24/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of pre-procedure anxiety on sedative requirements for sedation during upper gastrointestinal endoscopy
Scientific title
The effect of pre-procedure anxiety on sedative requirements for sedation during upper gastrointestinal endoscopy
Secondary ID [1] 286044 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety and sedative requirements 294022 0
Condition category
Condition code
Anaesthesiology 294323 294323 0 0
Anaesthetics
Mental Health 294857 294857 0 0
Anxiety
Oral and Gastrointestinal 294858 294858 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three hundred patients between the ages of 18-70 yr, ASA physical status I and II, scheduled to undergo planed upper gastro intestinal endoscopy, were studied. Fasting periods were in accordance with ASA guidelines. All patients were prepared to upper gastro intestinal endoscopy as a standard protocol.
Baseline anxiety levels were measured before the procedure while patients waited in the reception area. Each patient was asked to complete Spielberger’s State-Trait Anxiety Inventory (STAI) form X. The STAI measures both state and trait anxiety. STAI-X is subdivided into two different scales, STAI-X1 and -X2, used to evaluate state anxiety and trait anxiety, respectively. The STAI-X1 (State Anxiety) contains 20 items based on a 4-point Likert scale and ask the respondent how they feel “right now”. The total score may range from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated . Immediately after the admission into the reception area, the patients were asked to fill out the STAI-X1 questionnaire. Data were collected by an anaesthetist who was blind to sedation procedures.
A 20-gauge IV catheter was inserted in the right forearm before the patient arrived in the operating room. 0.9% saline infusion was used to keep the IV line open. BIS monitoring (BIS Monitor, Aspect 2000TM XP, USA) was applied to all patients in addition to routine monitoring (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff). After baseline measurements (haemodynamic profiles and BIS values) were obtained, the patient was placed in the left lateral position. Supplemental oxygen (4 l.min-1) was administered through a nasal canula.One milligram of midazolam were administered intravenously. Next, an initial intravenous dose of propofol (0.3–0.5 mg/kg of body weight) was administered, followed by repeated 10–20 mg doses so as to achieve BIS values 65-85 or the patient expressed discomfort. All drugs were administered until completion of endoscopy. Other medications, including analgesics, were not used in the present study. All sedation procedures were practised by an anaesthetist who was blind to pre-procedure anxiety scores.If there were any symptoms of respiratory depression or airway obstruction, a simple jaw thrust or chin lift maneuvers was performed.
All endoscopies, also blinded to the anxiety scores, were performed by one of three endoscopists, each of whom had performed more than 300 endoscopies before participating in the study. Endoscopist satisfaction were evaluated immediately after procedure by using a 10-cm visual analog scale. Patient satisfaction was measured using a 10-cm visual analog scale when the patients with a modified Aldrete score higher than or equal to 9.
Doses of propofol, total procedure time, satisfaction of patients and endoscopists and BIS values (Basal,after initial dose of propofol, at the second minute of the procedure, at the end of procedure) were recorded. Complications associated with the procedure (Abdominal distension, abdominal pain, nausea and vomiting) were also analyzed. We also recorded any complications associated with sedation (i.e. oxygen saturation < 90 %, blood pressure < 90/50 mm Hg, heart rate < 50 bpm).
Intervention code [1] 291032 0
Treatment: Drugs
Comparator / control treatment
There is no control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294123 0
Doses of propofol during endoscopy procedure.
Timepoint [1] 294123 0
Total doses of propofol (mg), (mg/kg) and mg/kg/min during endoscopy procedure.
Secondary outcome [1] 312558 0
Total procedure time
Timepoint [1] 312558 0
The time between the start and the end of endoscopy procedure
Secondary outcome [2] 312559 0
Satisfaction of patients
Timepoint [2] 312559 0
Evaluation will be done after the procedure with a scale between 0-10 (10 point Likert Scale)
Secondary outcome [3] 313719 0
Satisfaction of endoscopists
Timepoint [3] 313719 0
Evaluation will be done after the procedure with a scale between 0-10 (10 point Likert Scale)

Eligibility
Key inclusion criteria
Scheduled for elective upper gastrointestinal endoscopy.

ASA physical status I and II.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of any upper gastrointestinal surgery
A history of a psychiatric disease
Insufficient gastric preparation
A predicted difficult airway or allergy to propofol.
Non-elective patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2015
Actual
15/04/2015
Date of last participant enrolment
Anticipated
Actual
14/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 6610 0
Turkey
State/province [1] 6610 0
Konya

Funding & Sponsors
Funding source category [1] 290633 0
Hospital
Name [1] 290633 0
Konya Training and Research Hospital
Country [1] 290633 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA,
Postcode:42090
Country
Turkey
Secondary sponsor category [1] 289325 0
None
Name [1] 289325 0
Address [1] 289325 0
Country [1] 289325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292266 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 292266 0
Ethics committee country [1] 292266 0
Turkey
Date submitted for ethics approval [1] 292266 0
10/11/2014
Approval date [1] 292266 0
21/11/2014
Ethics approval number [1] 292266 0
2014/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54378 0
Dr Mehmet SARGIN
Address 54378 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 54378 0
Turkey
Phone 54378 0
+905322662766
Fax 54378 0
Email 54378 0
[email protected]
Contact person for public queries
Name 54379 0
Sadik OZMEN
Address 54379 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 54379 0
Turkey
Phone 54379 0
+903322212250
Fax 54379 0
Email 54379 0
[email protected]
Contact person for scientific queries
Name 54380 0
Sadik OZMEN
Address 54380 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 54380 0
Turkey
Phone 54380 0
+903322212250
Fax 54380 0
Email 54380 0
[email protected]

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