Desflurane versus Sevoflurane on postoperative recovery

The effect of desflurane versus Sevoflurane on postoperative recovery in patients undergoing minor- to moderate-risk noncardiac surgery - a prospective double-blinded randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000556-11-AT

Enrollment

190

Registered

2022-02-11

Start date

2022-04-26

Completion date

Unknown

Last updated

2023-10-03

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

Conditions

The evaluation of recovery times between desflurane and sevoflurane general anesthesia in patients = 65 years of age undergoing minor- to moderate-risk noncardiac surgery

Interventions

Trade Name: Suprane Product Name: Suprane Product Code: Desflurane Pharmaceutical Form: Inhalation vapour INN or Proposed INN: DESFLURANE CAS Number: 57041-67-5 Current Sponsor code: Desflurane Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.= 65 years of age at time of surgery 2.Scheduled for elective minor- to moderate-risk noncardiac surgery with expected time of surgery = 2 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 190

Exclusion criteria

Exclusion criteria: 1.Patients undergoing emergency surgery 2.Patients undergoing bariatric surgery 3.History of documented dementia / neurologic disorder 4.Language, vision, or hearing impairments that may compromise cognitive assessments 5.History of malignant hyperthermia 6.History of structural muscle diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: Our primary outcome will be the time (in minutes) from discontinuation of volatile anesthetic at the end of surgery until a modified Aldrete score of = 12 points will be reached. We will start to assess postoperative recovery using the modified Aldrete score after arrival at the postoperative care unit (PACU) and thereafter in five minutes intervals. The score consists of 7 modalities (Activity, Respiration, Circulation, Consciousness, Oxygenation, Pain and Emetic Symptoms) with a score of 0-2 points in each criterion.;Secondary Objective: Secondary Aim 1: The number of liters of supplemental oxygen administered in PACU for SpO2 = 93%. Secondary Aim 2: The difference in postoperative regional cerebral oxygen saturation (rSO2) between both study groups. Secondary Aim 3: Postoperative bispectral index values for maximum 90 minutes after surgery in both study groups. Secondary Aim 4: Self-assessed postoperative RHDS scores in both study groups. The evaluation consists of 8 questions with possible scores for each question of 0-10 points.;Primary end point(s): Time between discontinuation of desflurane/sevoflurane at the end of surgery until full postoperative recovery, which is defined as reaching = 12 out of 14 points in the modlified Aldrete score.;Timepoint(s) of evaluation of this end point: Upon arrival at the postoperative care unit in 5-minute intervals for a maximum of 90 minutes.	—

Measure

Time frame

Main Objective: Our primary outcome will be the time (in minutes) from discontinuation of volatile anesthetic at the end of surgery until a modified Aldrete score of = 12 points will be reached. We will start to assess postoperative recovery using the modified Aldrete score after arrival at the postoperative care unit (PACU) and thereafter in five minutes intervals. The score consists of 7 modalities (Activity, Respiration, Circulation, Consciousness, Oxygenation, Pain and Emetic Symptoms) with a score of 0-2 points in each criterion.;Secondary Objective: Secondary Aim 1: The number of liters of supplemental oxygen administered in PACU for SpO2 = 93%. Secondary Aim 2: The difference in postoperative regional cerebral oxygen saturation (rSO2) between both study groups. Secondary Aim 3: Postoperative bispectral index values for maximum 90 minutes after surgery in both study groups. Secondary Aim 4: Self-assessed postoperative RHDS scores in both study groups. The evaluation consists of 8 questions with possible scores for each question of 0-10 points.;Primary end point(s): Time between discontinuation of desflurane/sevoflurane at the end of surgery until full postoperative recovery, which is defined as reaching = 12 out of 14 points in the modlified Aldrete score.;Timepoint(s) of evaluation of this end point: Upon arrival at the postoperative care unit in 5-minute intervals for a maximum of 90 minutes.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Endpoint 1: The number of liters of supplemental oxygen administered in PACU for SpO2 = 93% between both study groups. Secondary Endpoint 2: Postoperative regional cerebral oxygen saturation (rSO2) between both study groups. Secondary Endpoint 3: Postoperative bispectral index values for maximum 90 minutes after surgery between both study groups. Secondary Endpoint 4: Self-assessed postoperative RHDS scores between both study groups.;Timepoint(s) of evaluation of this end point: Secondary Endpoint 1: during PACU stay for maximum 90 minutes Secondary Endpoint 2: during PACU stay for maximum 90 minutes Secondary Endpoint 3: during PACU stay for maximum 90 minutes Secondary Endpoint 4: on the evening of the day of surgery (18:00 – 22:00) and in the morning (05:00 – 11:00) and evening (18:00 – 22:00) for the following three days.	—

Measure

Time frame

Secondary end point(s): Secondary Endpoint 1: The number of liters of supplemental oxygen administered in PACU for SpO2 = 93% between both study groups. Secondary Endpoint 2: Postoperative regional cerebral oxygen saturation (rSO2) between both study groups. Secondary Endpoint 3: Postoperative bispectral index values for maximum 90 minutes after surgery between both study groups. Secondary Endpoint 4: Self-assessed postoperative RHDS scores between both study groups.;Timepoint(s) of evaluation of this end point: Secondary Endpoint 1: during PACU stay for maximum 90 minutes Secondary Endpoint 2: during PACU stay for maximum 90 minutes Secondary Endpoint 3: during PACU stay for maximum 90 minutes Secondary Endpoint 4: on the evening of the day of surgery (18:00 – 22:00) and in the morning (05:00 – 11:00) and evening (18:00 – 22:00) for the following three days.

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Countries

Austria

Contacts

Public ContactHead Office

Department of Anaesthesia, Intensive Care Medicine and Pain Medicine

sekretariat-anaesthesie@meduniwien.ac.at00434040041020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026