Postoperative DeliriumRecoveryNCT07714928
Recovery After Upper Extrimety Surgery
A study testing BIS-Guided General Anesthesia and Clinically Guided General Anesthesia in people with Postoperative Delirium and Postoperative Recovery in Elderly Patients, run by Region Örebro County at 1 site in Sweden.
Trial summary
The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or arm surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Delirium, Postoperative Recovery in Elderly Patients, Postoperative Cognitive Dysfunction (POCD)
- What is being tested?
- BIS-Guided General Anesthesia and Clinically Guided General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSweden
- Study dates
- 23 Jan 2015to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older.
- Scheduled to undergo hand or arm surgery using either intravenous regional anesthesia or general anesthesia.
- Able to understand the study information and provide informed consent.
- Able to complete the Postoperative Quality of Recovery Scale assessments and cognitive tests.
Who cannot join
- Inability to complete the recovery or cognitive assessments.
- Deafness or hearing impairment that prevented completion of the assessments.
- Bispectral Index monitoring could not be applied or used because of technical or surgical reasons.
- Expected duration of surgery of less than 30 minutes or more than 4 hours.
- Allergy to nuts or soybeans in participants scheduled to receive general anesthesia.
- Pregnancy.
- Substance abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anaesthetic Technique and How Anaesthesia is Titrated on the Postoperative Cognitive Performance and General Recovery Following Hand and Upper Extremity Surgery.
The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or arm surgery.
The main questions it aims to answer are:
Read more
Does BIS-guided anesthesia improve postoperative cognitive recovery compared with general anesthesia guided by routine clinical signs?
Does BIS-guided anesthesia improve overall postoperative recovery, as measured by the Postoperative Quality of Recovery Scale (PQRS)?
Researchers will compare patients receiving BIS-guided general anesthesia with patients receiving clinically guided general anesthesia, in which the BIS monitor records data but the displayed values are concealed from the anesthesia team, to determine whether BIS-guided anesthetic management improves postoperative recovery. An additional comparison group will consist of patients undergoing surgery under intravenous regional anesthesia without general anesthesia.
Participants will:
undergo elective hand or arm surgery; receive either BIS-guided or clinically guided general anesthesia, or intravenous regional anesthesia without general anesthesia; complete PQRS assessments before surgery and at multiple postoperative time points, including follow-up for up to three months.
Read the detailed description
The study was designed to investigate the relationship between anesthetic technique, depth of general anesthesia, and postoperative cognitive and overall recovery following elective surgery of the hand or arm.Patients scheduled to receive general anesthesia were randomly allocated using sealed envelopes to one of two general-anesthesia groups. In the BIS-guided group, anesthetic delivery was adjusted using the Bispectral Index, with a target BIS range of 40 to 60. In the clinically guided group, anesthesia was adjusted according to routine clinical indicators, such as blood pressure, heart rate, movement, and other clinical signs. BIS monitoring was also connected in this group, but the values were concealed from the anesthesia personnel and stored for later analysis.General anesthesia was induced with propofol and maintained using sevoiurane and remifentanil according to the study protocol and routine clinical practice. Standard intraoperative monitoring included electrocardiography, noninvasive blood-pressure measurement, oxygen saturation, temperature, and BIS monitoring. Perioperative fluids, treatment of blood-pressure changes, analgesia, and prevention or treatment of postoperative nausea were managed according to the study protocol and usual clinical routines.A separate comparison group consisted of patients whose planned operation was performed using intravenous regional/local anesthesia without general anesthesia. These patients were not randomly assigned to the regional-anesthesia group; their anesthetic method had already been selected as part of their clinical surgical plan.Postoperative recovery was evaluated using the Postoperative Quality of Recovery Scale.
Each participant completed a preoperative baseline assessment, and postoperative assessments were planned at approximately 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery. The scale assessed physiological recovery, pain and postoperative nausea or vomiting, emotional recovery, cognitive performance, activities of daily living, and overall patient-reported recovery.Cognitive assessments included orientation, forward digit recall, backward digit recall, word recall, and word generation.
Postoperative performance was compared with each participant's own preoperative baseline rather than with a single population-level cutoff.The prospect primary assessment was cognitive recovery at 48 hours after surgery. Additional assessments examined recovery at the other postoperative time points, anesthetic exposure, recorded BIS values, perioperative physiological variables, and early postoperative recovery.
- Conditions
- Postoperative Delirium, Postoperative Recovery in Elderly Patients, Postoperative Cognitive Dysfunction (POCD)
- Being tested
- BIS-Guided General Anesthesia, Clinically Guided General Anesthesia
- Keywords
- bispectraindex, sevoflurane, anesthesia, elderly, cognition
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS-Guided General AnesthesiaProcedure or surgery
General anesthesia was guided by visible Bispectral Index monitoring. Anesthetic delivery was adjusted to maintain a BIS value between 40 and 60. The protocol included propofol for induction and remifentanil with a volatile anesthetic for maintenance.
Clinically Guided General AnesthesiaProcedure or surgery
General anesthesia was guided by routine clinical indicators of anesthetic depth. BIS monitoring was recorded, but its values were concealed from the anesthesia personnel and were not used to adjust anesthetic delivery. The anesthetic regimen otherwise followed the same protocol as the BIS-guided group.
| Study group | Role | What they receive |
|---|---|---|
| BIS-Guided General Anesthesia | Experimental | Participants scheduled for general anesthesia were randomized to anesthesia guided by visible Bispectral Index monitoring. The anesthesia team adjusted anesthetic delivery using a target BIS range of 40 to 60. General anesthesia was induced with propofol and maintained with a volatile anesthetic and remifentanil according to the study protocol. Receives: Procedure: BIS-Guided General Anesthesia |
| Clinically Guided General Anesthesia | Active comparator | Participants scheduled for general anesthesia were randomized to anesthesia guided by routine clinical signs. BIS monitoring was connected and recorded throughout anesthesia, but the BIS display was concealed from the anesthesia personnel and was not used to guide anesthetic delivery. The anesthetic regimen otherwise followed the same study protocol as the BIS-guided group. Receives: Procedure: Clinically Guided General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Cognitive Recovery at 48 Hours
Cognitive recovery was assessed using the cognitive domain of the Postoperative Quality of Recovery Scale (PQRS). The domain included orientation, forward digit recall, backward digit recall, word recall, and word generation. Each participant's postoperative performance was compared with that participant's preoperative baseline using the PQRS recovery criteria. A participant was classiMed as cognitively recovered when all applicable cognitive subtests met the recovery criteria. The outcome was reported as the number and percentage of participants cognitively recovered
Measured: 48 hours after surgery
Secondary outcomes (8)
Participants With Cognitive Recovery at Other Postoperative Time Points
Cognitive recovery was assessed using the Mve PQRS cognitive subtests: orientation, forward digit recall, backward digit recall, word recall, and word generation. Postoperative performance was compared with each participant's own preoperative baseline using the PQRS recovery criteria. The outcome was reported as the number and percentage of participants cognitively recovered at each time point.
Measured: 20 minutes, 40 minutes, 24 hours, 14 days, and 90 days after surgery
Participants With Overall Postoperative Quality of Recovery
Overall recovery was assessed using the applicable domains of the PQRS (physiological recovery, nociception, emotional recovery, cognition, activities of daily living, and overall patient perspective). Participants were classified as having achieved overall recovery when recovery criteria were met in all applicable PQRS domains, based on comparison with the participant's preoperative baseline where applicable. The outcome was reported as the number and percentage of participants achieving overall recovery.
Measured: 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Meeting PQRS Physiological Recovery Criteria
Physiological recovery was assessed from the PQRS physiological domain, which incorporates systolic blood pressure, heart rate, body temperature, respiratory rate, oxygen saturation, oxygen requirement, airway maintenance, agitation, level of consciousness, and ability to follow a simple command. Recovery was determined according to predefined PQRS physiological recovery criteria. Participants were classified as physiologically recovered when all applicable physiological recovery criteria were met. The outcome was reported as the number and percentage of participants meeting PQRS physiological recovery criteria.
Measured: Immediately after emergence and at 20 and 40 minutes after surgery
Postoperative Pain Severity Assessed With PQRS
Pain was rated using the PQRS nociceptive-domain pain item on a five-category scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; and 5, worst imaginable pain. Lower scores indicated less pain. The outcome was reported as pain severity score at each postoperative assessment.
Measured: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Participants Meeting PQRS Emotional Rcovery Criteria
Emotional recovery was assessed using separate PQRS ratings for depression or sadness and anxiety or nervousness. Each item ranged from 1, not at all, to 5, extreme symptoms, with lower scores indicating better emotional status. Recovery was determined according to PQRS emotional recovery criteria by comparison with the participant's preoperative baseline. The outcome was reported as the number and percentage of participants meeting emotional recovery criteria.
Measured: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Postoperative nausea and vomiting
Nausea, retching, and vomiting were assessed using the PQRS nociceptive-domain nausea and vomiting item. Scores ranged from 1, no nausea, retching, or vomiting, to 5, continuous retching or vomiting. Lower scores indicated fewer symptoms. Nausea and vomiting severity scores were assessed and summarized at each postoperative time point.
Measured: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Participants Meeting PQRS Activities of Daily Living Recovery Criteria
Activities of daily living were assessed through the participant's ability to stand, walk, eat and drink, and dress without assistance. Each activity was rated as 1, unable; 2, able with difficulty; or 3, able with ease. Higher scores indicated better function. Recovery was determined according to PQRS activities of daily living recovery criteria by comparison with the participant's preoperative baseline. Participants were classified as recovered when all applicable activities met recovery criteria. The outcome was reported as the number and percentage of participants meeting activities of daily living recovery criteria.
Measured: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Patient-Reported Overall Recovery and Satisfaction Assessed With PQRS
The PQRS overall-perspective domain assessed the perceived effect of surgery on the participant's overall perspective of recovery and satisfaction with anesthesia. Items were rated on five-category scales, with lower scores indicating less negative impact or greater satisfaction. Recovery was determined according to PQRS overall-perspective recovery criteria. The outcome was reported as the number and percentage of participants meeting overall-perspective recovery criteria at each postoperative assessment.
Measured: 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start23 Jan 2015
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups were studied. Patients whose planned surgery was to be performed under intravenous regional anesthesia entered a nonrandomized regional-anesthesia comparison group. Patients scheduled for general anesthesia were randomized using sealed envelopes to either BIS-guided anesthesia, targeting a Bispectral Index value of 40 to 60, or clinically guided anesthesia in which BIS values were recorded but concealed from the anesthesia personnel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pether Jildenstål, PhD, Professor, Study director, Department of Anesthesia and intensivecare University Hospital Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714928
- Sponsor's protocol ID
- 2014-004024-22
- Other IDs
- 2014/378, 2014
- Acronym
- Recovery
- Status last verified
- Jan 2015
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the original participant consent and ethics documentation did not include a prospective plan for external sharing of participant-level data. Study data are coded and access is restricted to the authorized research team. Results will be reported in aggregated form. Any future request for data access would require separate review and approval by the study sponsor, data controller, and relevant ethics and data-protection authorities.
Publications
Newman S, Wilkinson DJ, Royse CF. Assessment of early cognitive recovery after surgery using the Post-operative Quality of Recovery Scale. Acta Anaesthesiol Scand. 2014 Feb;58(2):185-91. doi: 10.1111/aas.12234. Epub 2013 Nov 22.
PubMed 24410107Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
PubMed 20601860Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
PubMed 23027226Jildenstal P, Eriksson J, Warren Stomberg M, Jakobsson JG. Evaluation of the Postoperative Quality of Recovery Scale test and re-test in Swedish among healthy volunteers. F1000Res. 2016 Oct 21;5:2549. doi: 10.12688/f1000research.9740.1. eCollection 2016.
PubMed 28299175
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anaesthetic Technique and How Anaesthesia is Titrated on the Postoperative Cognitive Performance and General Recovery Following Hand and Upper Extremity Surgery.
- ClinicalTrials.gov ID
- NCT07714928
- Acronym / sponsor ID
- Recovery / 2014-004024-22
- Conditions
- Postoperative Delirium, Postoperative Recovery in Elderly Patients, Postoperative Cognitive Dysfunction (POCD)
- Keywords
- bispectraindex, sevoflurane, anesthesia, elderly, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 23 Jan 2015 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or arm surgery.
The main questions it aims to answer are:
Does BIS-guided anesthesia improve postoperative cognitive recovery compared with general anesthesia guided by routine clinical signs?
Does BIS-guided anesthesia improve overall postoperative recovery, as measured by the Postoperative Quality of Recovery Scale (PQRS)?
Researchers will compare patients receiving BIS-guided general anesthesia with patients receiving clinically guided general anesthesia, in which the BIS monitor records data but the displayed values are concealed from the anesthesia team, to determine whether BIS-guided anesthetic management improves postoperative recovery. An additional comparison group will consist of patients undergoing surgery under intravenous regional anesthesia without general anesthesia.
Participants will:
undergo elective hand or arm surgery; receive either BIS-guided or clinically guided general anesthesia, or intravenous regional anesthesia without general anesthesia; complete PQRS assessments before surgery and at multiple postoperative time points, including follow-up for up to three months.
Detailed description
The study was designed to investigate the relationship between anesthetic technique, depth of general anesthesia, and postoperative cognitive and overall recovery following elective surgery of the hand or arm.Patients scheduled to receive general anesthesia were randomly allocated using sealed envelopes to one of two general-anesthesia groups. In the BIS-guided group, anesthetic delivery was adjusted using the Bispectral Index, with a target BIS range of 40 to 60. In the clinically guided group, anesthesia was adjusted according to routine clinical indicators, such as blood pressure, heart rate, movement, and other clinical signs. BIS monitoring was also connected in this group, but the values were concealed from the anesthesia personnel and stored for later analysis.General anesthesia was induced with propofol and maintained using sevoiurane and remifentanil according to the study protocol and routine clinical practice. Standard intraoperative monitoring included electrocardiography, noninvasive blood-pressure measurement, oxygen saturation, temperature, and BIS monitoring. Perioperative fluids, treatment of blood-pressure changes, analgesia, and prevention or treatment of postoperative nausea were managed according to the study protocol and usual clinical routines.A separate comparison group consisted of patients whose planned operation was performed using intravenous regional/local anesthesia without general anesthesia. These patients were not randomly assigned to the regional-anesthesia group; their anesthetic method had already been selected as part of their clinical surgical plan.Postoperative recovery was evaluated using the Postoperative Quality of Recovery Scale.
Each participant completed a preoperative baseline assessment, and postoperative assessments were planned at approximately 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery. The scale assessed physiological recovery, pain and postoperative nausea or vomiting, emotional recovery, cognitive performance, activities of daily living, and overall patient-reported recovery.Cognitive assessments included orientation, forward digit recall, backward digit recall, word recall, and word generation.
Postoperative performance was compared with each participant's own preoperative baseline rather than with a single population-level cutoff.The prospect primary assessment was cognitive recovery at 48 hours after surgery. Additional assessments examined recovery at the other postoperative time points, anesthetic exposure, recorded BIS values, perioperative physiological variables, and early postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Three parallel groups were studied. Patients whose planned surgery was to be performed under intravenous regional anesthesia entered a nonrandomized regional-anesthesia comparison group. Patients scheduled for general anesthesia were randomized using sealed envelopes to either BIS-guided anesthesia, targeting a Bispectral Index value of 40 to 60, or clinically guided anesthesia in which BIS values were recorded but concealed from the anesthesia personnel.
| Arm | Type | Receives |
|---|---|---|
| BIS-Guided General Anesthesia | Experimental | Procedure: BIS-Guided General AnesthesiaParticipants scheduled for general anesthesia were randomized to anesthesia guided by visible Bispectral Index monitoring. The anesthesia team adjusted anesthetic delivery using a target BIS range of 40 to 60. General anesthesia was induced with propofol and maintained with a volatile anesthetic and remifentanil according to the study protocol. |
| Clinically Guided General Anesthesia | Active comparator | Procedure: Clinically Guided General AnesthesiaParticipants scheduled for general anesthesia were randomized to anesthesia guided by routine clinical signs. BIS monitoring was connected and recorded throughout anesthesia, but the BIS display was concealed from the anesthesia personnel and was not used to guide anesthetic delivery. The anesthetic regimen otherwise followed the same study protocol as the BIS-guided group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older.
- Scheduled to undergo hand or arm surgery using either intravenous regional anesthesia or general anesthesia.
- Able to understand the study information and provide informed consent.
- Able to complete the Postoperative Quality of Recovery Scale assessments and cognitive tests.
Key exclusion criteria (7 listed)
- Inability to complete the recovery or cognitive assessments.
- Deafness or hearing impairment that prevented completion of the assessments.
- Bispectral Index monitoring could not be applied or used because of technical or surgical reasons.
- Expected duration of surgery of less than 30 minutes or more than 4 hours.
- Allergy to nuts or soybeans in participants scheduled to receive general anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS-Guided General AnesthesiaGeneral anesthesia was guided by visible Bispectral Index monitoring. Anesthetic delivery was adjusted to maintain a BIS value between 40 and 60. The protocol included propofol for induction and remifentanil with a volatile anesthetic for maintenance. | Procedure or surgery | BIS-Guided General Anesthesia |
| Clinically Guided General AnesthesiaGeneral anesthesia was guided by routine clinical indicators of anesthetic depth. BIS monitoring was recorded, but its values were concealed from the anesthesia personnel and were not used to adjust anesthetic delivery. The anesthetic regimen otherwise followed the same protocol as the BIS-guided group. | Procedure or surgery | Clinically Guided General Anesthesia |
Primary outcome
Participants With Cognitive Recovery at 48 Hours
Time frame: 48 hours after surgery
Cognitive recovery was assessed using the cognitive domain of the Postoperative Quality of Recovery Scale (PQRS). The domain included orientation, forward digit recall, backward digit recall, word recall, and word generation. Each participant's postoperative performance was compared with that participant's preoperative baseline using the PQRS recovery criteria. A participant was classiMed as cognitively recovered when all applicable cognitive subtests met the recovery criteria. The outcome was reported as the number and percentage of participants cognitively recovered
8 secondary outcomes
Participants With Cognitive Recovery at Other Postoperative Time Points
Time frame: 20 minutes, 40 minutes, 24 hours, 14 days, and 90 days after surgery
Participants With Overall Postoperative Quality of Recovery
Time frame: 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Meeting PQRS Physiological Recovery Criteria
Time frame: Immediately after emergence and at 20 and 40 minutes after surgery
Postoperative Pain Severity Assessed With PQRS
Time frame: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Participants Meeting PQRS Emotional Rcovery Criteria
Time frame: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Postoperative nausea and vomiting
Time frame: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Participants Meeting PQRS Activities of Daily Living Recovery Criteria
Time frame: Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Patient-Reported Overall Recovery and Satisfaction Assessed With PQRS
Time frame: 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 24410107Newman S, Wilkinson DJ, Royse CF. Assessment of early cognitive recovery after surgery using the Post-operative Quality of Recovery Scale. Acta Anaesthesiol Scand. 2014 Feb;58(2):185-91. doi: 10.1111/aas.12234. Epub 2013 Nov 22.
- Results publication: PubMed 20601860Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
- Results publication: PubMed 23027226Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.
- Results publication: PubMed 28299175Jildenstal P, Eriksson J, Warren Stomberg M, Jakobsson JG. Evaluation of the Postoperative Quality of Recovery Scale test and re-test in Swedish among healthy volunteers. F1000Res. 2016 Oct 21;5:2549. doi: 10.12688/f1000research.9740.1. eCollection 2016.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the original participant consent and ethics documentation did not include a prospective plan for external sharing of participant-level data. Study data are coded and access is restricted to the authorized research team. Results will be reported in aggregated form. Any future request for data access would require separate review and approval by the study sponsor, data controller, and relevant ethics and data-protection authorities.
Related trials for Postoperative Delirium
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pether Jildenstål, PhD, Professor study director
Department of Anesthesia and intensivecare University Hospital Örebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS-Guided General Anesthesia and Clinically Guided General Anesthesia in people with Postoperative Delirium and Postoperative Recovery in Elderly Patients, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Cognitive Recovery at 48 Hours (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07714928, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.