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The effect of pre-procedure anxiety on sedative requirements for sedation during upper gastrointestinal endoscopy

The effect of pre-procedure anxiety on sedative requirements for sedation during upper gastrointestinal endoscopy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000369527
Enrollment
300
Registered
2015-04-22
Start date
2015-04-15
Completion date
2015-12-14
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Fear and anxiety were observed in many patients before operations and similar procedures. Anxiety was observed in % 60-80 of patients who was planned to go surgery. Although these anxiety and fear are releated to the type of anesthesia, they may be releated to previous experiences, personality features, anxiety about surgery and postoperative pain. Level of anxiety in patients may be effected by many factors such as previous experiences, gender, age and type of surgery. The most common test which was used to measure level of anxiety is STAI (State-Trait Anxiety Inventory) scale that was improved by Spielberg at all. In the present study ,it was aimed to asses preoperative anxiety level and effect of anxiety level on quantity of sedative agents used by using STAI anxiety scale.

Interventions

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

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).

Sponsors

Konya Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Scheduled for elective upper gastrointestinal endoscopy. ASA physical status I and II.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026