Incidence and Severity of Postoperative Delirium and Agitation After Shoulder Surgery: Comparison Between Regional Anesthesia Alone and Combined Regional–General Anesthesia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260203068755N1

Enrollment

Registered

2026-05-13

Start date

2026-02-14

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Shoulder surgery. Injuries to the shoulder and upper arm

Interventions

Intervention group: Combined regional–general anesthesia. Ultrasound-guided interscalene brachial plexus block will be performed preoperatively followed by standardized general anesthesia (IV inductio

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult patients scheduled for elective shoulder surgery ASA physical status I–III Candidate for regional anesthesia (interscalene block) Ability to provide informed consent

Exclusion criteria

Exclusion criteria: Pre-existing cognitive impairment or dementia History of delirium, psychosis, or major psychiatric illness Chronic use of antipsychotics or sedative-hypnotics Alcohol or substance abuse Severe hearing/communication problems preventing assessment Contraindications to regional anesthesia (infection at site, coagulopathy, allergy to local anesthetics) Emergency surgery

Design outcomes

Primary

Measure	Time frame
• Incidence of postoperative delirium (PACU and within the first 24 hours after surgery) • Severity of postoperative delirium (PACU and within the first 24 hours after surgery) • Incidence of emergence agitation (during emergence and in PACU) • Severity of emergence agitation (peak agitation score during emergence and in PACU). Timepoint: : Primary outcomes will be assessed at the following timepoints:1-Baseline (preoperative assessment, before anesthesia/intervention)2-Immediately after emergence from anesthesia (at awakening/extubation)3-During PACU stay (within the first 60 minutes postoperatively)4-6 hours after surgery5-24 hours after surgery. Method of measurement: Measurement of Primary Outcome Variables1) Postoperative delirium (incidence and severity)•Tool (incidence): Confusion Assessment Method (CAM) for ward assessments; CAM-ICU if assessed in PACU/ICU-style setting for nonverbal or heavily sedated patients.•How measured: A trained blinded assessor performs CAM/CAM-ICU at each scheduled timepoint; delirium is recorded as present/absent based on the tool’s algorithm.•Tool (severity): CAM-S (Confusion Assessment Method–Severity score) or a validated delirium severity scale available at your center (e.g., DRS-R-98 if used locally).•How measured: Severity is documented as the total score at each timepoint; the highest score within 24 hours can be used as the main severity metric.2) Emergence agitation (incidence and severity)•Tool: Richmond Agitation–Sedation Scale (RASS) (or Riker Sedation–Agitation Scale (SAS) if that is your institutional standard).•How measured: The blinded assessor rates the patient during emergence and in PACU.oIncidence: agitation defined as RASS = +2 (or SAS = 5, if SAS is used).oSeverity: recorded as the peak agitation scor	—

Measure

Time frame

• Incidence of postoperative delirium (PACU and within the first 24 hours after surgery) • Severity of postoperative delirium (PACU and within the first 24 hours after surgery) • Incidence of emergence agitation (during emergence and in PACU) • Severity of emergence agitation (peak agitation score during emergence and in PACU). Timepoint: : Primary outcomes will be assessed at the following timepoints:1-Baseline (preoperative assessment, before anesthesia/intervention)2-Immediately after emergence from anesthesia (at awakening/extubation)3-During PACU stay (within the first 60 minutes postoperatively)4-6 hours after surgery5-24 hours after surgery. Method of measurement: Measurement of Primary Outcome Variables1) Postoperative delirium (incidence and severity)•Tool (incidence): Confusion Assessment Method (CAM) for ward assessments; CAM-ICU if assessed in PACU/ICU-style setting for nonverbal or heavily sedated patients.•How measured: A trained blinded assessor performs CAM/CAM-ICU at each scheduled timepoint; delirium is recorded as present/absent based on the tool’s algorithm.•Tool (severity): CAM-S (Confusion Assessment Method–Severity score) or a validated delirium severity scale available at your center (e.g., DRS-R-98 if used locally).•How measured: Severity is documented as the total score at each timepoint; the highest score within 24 hours can be used as the main severity metric.2) Emergence agitation (incidence and severity)•Tool: Richmond Agitation–Sedation Scale (RASS) (or Riker Sedation–Agitation Scale (SAS) if that is your institutional standard).•How measured: The blinded assessor rates the patient during emergence and in PACU.oIncidence: agitation defined as RASS = +2 (or SAS = 5, if SAS is used).oSeverity: recorded as the peak agitation scor

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShayan Kamalfar

Shahid Beheshti University of Medical Sciences

shayankamalfar@sbmu.ac.ir+98 922 769 5794

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026