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IRCT20260203068755N1 IRCT 2026-05-13 Shahid Beheshti University of Medical Sciences Incidence and Severity of Postoperative Delirium and Agitation After Shoulder Surgery: Comparison Between Regional Anesthesia Alone and Combined Regional–General Anesthesia Incidence and Severity of Postoperative Delirium and Agitation After Shoulder Surgery: Comparison Between Regional Anesthesia Alone and Combined Regional–General Anesthesia 2026-02-14 anticipated 80 Recruiting https://irct.ir/trial/89119 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: 1) Allocation ratio Eligible participants will be allocated in a 1:1 ratio into two parallel groups: Group A: Regional anesthesia alone (RA) Group B: Combined regional + general anesthesia (RA+GA) 2) Sequence generation (how the random list is created) An independent person (e.g., a statistician or a researcher not involved in anesthesia delivery or outcome assessment) will generate the randomization sequence. A computer-generated random sequence will be created using software such as Randomization.com, SPSS, or Microsoft Excel. To ensure balance between the groups during recruitment, block randomization will be used. 3) Block randomization (to keep groups balanced) Variable block sizes will be applied to reduce predictability (e.g., block sizes of 4 and 6, randomly mixed). Within each block, equal numbers of participants will be assigned to each group, but the order will be randomized. Example: In a block of 4, 2 patients will be allocated to RA and 2 to RA+GA, but in random order. 4) Allocation concealment (preventing prediction) To ensure that no one can predict the next assignment, allocation concealment will be performed using the standard SNOSE method: Sealed, Opaque, Sequentially Numbered Envelopes (SNOSE) Envelopes will be opaque, light-proof, sealed, and sequentially numbered (001 to 060). Each envelope will contain a paper indicating the assigned group (RA or RA+GA). Envelopes will be prepared and sealed by an independent researcher. The envelopes will be stored securely until use. 5) Implementation (when and who opens the envelope) After confirming eligibility and obtaining written informed consent, each participant will receive a study ID (e.g., 001, 002, …, 060). The anesthesia provider (who is not blinded) will open the corresponding envelope immediately before anesthesia induction. The group allocation will be recorded in a confidential allocation log. 6) Documentation and quality control The master randomization list will remain with the independent statistician and will not be accessible to assessors. Used envelopes will be retained for auditing and verification. Any protocol deviations will be documented. 7) Cross-over management and analysis plan If a participant allocated to RA alone requires conversion to general anesthesia for clinical reasons: General anesthesia will be administered as needed (patient safety is the priority). The case will be recorded as a protocol deviation/crossover. The participant will remain in the original allocated group for the primary analysis based on the Intention-To-Treat (ITT) principle. A secondary Per-Protocol (PP) analysis may also be performed, Blinding description: Because the interventions are anesthesia techniques, full blinding of the anesthesia provider is not possible. However, this study will be implemented as a practical double-blind trial, meaning: Participants will be blinded Postoperative outcome assessors will be blinded Data analysts/statisticians will be blinded The anesthesia provider delivering anesthesia will not be blinded 1) Participant blinding Participants will not be informed about their group assignment. To maintain participant blinding: Both groups will undergo similar preoperative preparation and operating room workflow. All patients will receive an ultrasound-guided interscalene block. To minimize the patient’s ability to identify the anesthetic technique, standardized light sedation may be used when clinically appropriate. The informed consent will state that the patient will receive one of two standard anesthesia approaches. 2) Outcome assessor blinding Postoperative delirium and agitation will be assessed by trained personnel (e.g., PACU nurse/research assistant) who: Are not involved in anesthesia delivery Do not have access to anesthesia records Will assess outcomes only using the participant study ID Assessment tools may include: Confusion Assessment Method (CAM) / CAM-ICU Richmond Agitation-Sedation Scale (RASS) or Sedation-Agitation Scale 3) Data analyst blinding All collected data will be entered into the database using coded group labels (Group A and Group B). The statistician will receive the dataset without knowing which group corresponds to RA or RA+GA. Group identity will be revealed only after completion of the primary statistical analysis. 4) Standardization of perioperative care to maintain blinding To reduce the chance of group disclosure: Postoperative pain control, antiemetic use, and sedation protocols will be standardized across groups. The anesthesia record will be kept separate from the outcome assessment forms. PACU and ward staff will be instructed not to discuss anesthesia type in the presence of the blinded assessor. 5) Prevention and documentation of unblinding Assessors will not be allowed to review the anesthesia chart. If unblinding is suspected (e.g., the assessor guesses the group), this will be recorded in a separate form as “assessor guess of allocation” to evaluate blinding quality. 6) Emergency unblinding Emergency unblinding will be permitted only if knowledge of the anesthetic technique is clinically essential for patient management. The reason for unblinding will be documented. The date/time and personnel involved will be recorded. The participant will still remain in the ITT analysis. N/A Shoulder surgery. Intervention group: Combined regional–general anesthesia. Ultrasound-guided interscalene brachial plexus block will be performed preoperatively followed by standardized general anesthesia (IV induction, airway management, and maintenance with inhalational anesthetic) in addition to the regional block.. Yes - There is a plan to make this available What will be shared: Data regarding anesthesia and outcomes measurements will be available. When: After data collection completion To whom: Other researchers Conditions: belonging to academic institution Where to obtain: researcher's personal email shayankamalfar@sbmu.ac.ir How to obtain: requesting by email Comments:
public Shayan Kamalfar
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
Tehran Iran (Islamic Republic of) 1983963113 +98 922 769 5794 shayankamalfar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Shayan Kamalfar
Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2303 1290 shayankamalfar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Adult patients scheduled for elective shoulder surgery ASA physical status I–III Candidate for regional anesthesia (interscalene block) Ability to provide informed consent 18 years 65 years Both 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 S40-S49 Injuries to the shoulder and upper arm Treatment - Drugs Intervention group: Combined regional–general anesthesia. Ultrasound-guided interscalene brachial plexus block will be performed preoperatively followed by standardized general anesthesia (IV induction, airway management, and maintenance with inhalational anesthetic) in addition to the regional block. • 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.o Incidence: agitation defined as RASS ≥ +2 (or SAS ≥ 5, if SAS is used).o Severity: recorded as the peak agitation score (maximum RASS/SAS value) during emergence and PACU observation.Standardization and blinding• All assessments will be performed by trained staff blinded to group allocation, using standardized instructions, and recorded on a predefined case report form.If you tell me which scales your hospital already uses (CAM vs CAM-ICU only, and RASS vs SAS), I can lock it to one exact tool to match your protocol perfectly. Shahid Beheshti University of Medical Sciences Approved 2026-01-31 School of Medicine - Shahid Beheshti University of Medical Sciences (Research Ethics Committee) Shahid Chamran Highway- Evin- next to Taleghani Hospital- Medical School- third floor Tehran Tehran Iran (Islamic Republic of)