Use of Zolpidem to help patients with fear of magnetic resonance imaging compared to traditional sedation

Zolpidem in the management of claustrophobia during magnetic resonance imaging: a non-inferiority study compared to conventional sedation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-23pfcg5

Enrollment

303

Registered

2026-02-11

Start date

2023-07-03

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Claustrophobia

Interventions

Open-label, non-randomized, non-inferiority clinical trial with two arms, conducted at the Sorocaba Diagnostic Institute, Brazil. Participants aged over 18 and under 70 years were included

they were referred for a closed-field magnetic resonance imaging (MRI) examination and reported procedure-related phobia at the time of scheduling. In the experimental group, participants received zol

Eligibility

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Individuals referred to the IDS group for magnetic resonance imaging studies under sedation between July 3, 2023, and August 3, 2024; individuals who report claustrophobia at the time of exam scheduling; age older than 18 years and younger than 70 years.

Exclusion criteria

Exclusion criteria: Individuals who do not provide written informed consent; individuals who do not meet the inclusion criteria; individuals with absolute contraindications to zolpidem use, including hepatic impairment, renal impairment, severe pulmonary diseases, pregnancy, or breastfeeding; age younger than 18 years or older than 70 years; current or chronic use of Zolpidem.

Design outcomes

Primary

Measure	Time frame
Expected Outcomes 1: Zolpidem is expected to be non-inferior to conventional sedation in the management of claustrophobia in patients undergoing closed-bore magnetic resonance imaging, with a non-inferiority margin of 10%.;Observed Outcome 1: Zolpidem demonstrated non-inferiority compared with conventional sedation, with a non-inferiority margin of 3.06%.;Expected Outcome 2: Zolpidem is not expected to produce clinically relevant effects on physiological and metabolic parameters, including heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation (SpO2), and blood glucose levels before and after the examination, compared with conventional sedation.;Observed Outcome 2: Zolpidem did not produce clinically relevant effects on physiological and metabolic parameters, including heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation (SpO2), and blood glucose levels before and after the examination, compared with conventional sedation.;Expected Outcome 3: Administration of zolpidem is not expected to trigger moderate or severe adverse events. ;Observed Outcome 3: No moderate or severe adverse events were observed after zolpidem administration.;Expected Outcome 4: A direct correlation is expected between adverse effects following zolpidem administration and age, with a higher prevalence among older adults.;Observed Outcome 4: No direct correlation was observed between adverse effects following zolpidem administration and participants’ age.;Expected Outcome 5: The procedure performed with zolpidem is expected to be associated with an approximate 80% reduction in costs compared with conventional sedation.;Observed Outcome 5: The procedure performed with zolpidem resulted in a 99.9% reduction in costs compared with conventional sedation.	—

Measure

Time frame

Expected Outcomes 1: Zolpidem is expected to be non-inferior to conventional sedation in the management of claustrophobia in patients undergoing closed-bore magnetic resonance imaging, with a non-inferiority margin of 10%.;Observed Outcome 1: Zolpidem demonstrated non-inferiority compared with conventional sedation, with a non-inferiority margin of 3.06%.;Expected Outcome 2: Zolpidem is not expected to produce clinically relevant effects on physiological and metabolic parameters, including heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation (SpO2), and blood glucose levels before and after the examination, compared with conventional sedation.;Observed Outcome 2: Zolpidem did not produce clinically relevant effects on physiological and metabolic parameters, including heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation (SpO2), and blood glucose levels before and after the examination, compared with conventional sedation.;Expected Outcome 3: Administration of zolpidem is not expected to trigger moderate or severe adverse events. ;Observed Outcome 3: No moderate or severe adverse events were observed after zolpidem administration.;Expected Outcome 4: A direct correlation is expected between adverse effects following zolpidem administration and age, with a higher prevalence among older adults.;Observed Outcome 4: No direct correlation was observed between adverse effects following zolpidem administration and participants’ age.;Expected Outcome 5: The procedure performed with zolpidem is expected to be associated with an approximate 80% reduction in costs compared with conventional sedation.;Observed Outcome 5: The procedure performed with zolpidem resulted in a 99.9% reduction in costs compared with conventional sedation.

—

Countries

Brazil

Contacts

Public ContactBeatriz Nascimento

IDS - Instituto de Diagnósticos

drabeatriz@ids.med.br+551530360100

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 14, 2026