Repeated verbal orientation reminders to reduce emergence agitation after general anesthesia
Effect of a Repeated Verbal Reminder of Orientation on Emergence Agitation After General Anesthesia
We'll try prerecorded verbal orientation reminders through headphones to see if they reduce wake-up agitation in adults (18–70) having elective laparoscopic abdominal surgery with sevoflurane general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shaukat Khanum Memorial Cancer Hospital & Research Centre Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07510516 on ClinicalTrials.gov |
What this trial studies
The trial will enroll 42 adults aged 18–70 scheduled for elective laparoscopic abdominal surgery at Shaukat Khanum Memorial Hospital, Lahore. Participants will be randomized 1:1 to an orientation group receiving repeated prerecorded voice reminders via headphones or to a control group who only hear their own name. Emergence agitation will be measured in the operating room using the Riker Sedation-Agitation Scale, with incidence of emergence agitation as the primary outcome. Secondary outcomes include time from sevoflurane discontinuation to eye opening, extubation, discharge to PACU, pain scores, and length of PACU stay.
Who should consider this trial
Good fit: Adults 18–70 scheduled for elective laparoscopic abdominal surgery under sevoflurane general anesthesia without hearing loss, documented cognitive or neurological deficits, BMI >35, ASA IV status, or current antipsychotic use are ideal candidates.
Not a fit: Patients planned for TIVA or inhalational agents other than sevoflurane, ambulatory surgery, those with hearing impairment, documented cognitive or neurologic deficits, very high BMI, ASA 4, or on antipsychotics are unlikely to be eligible or to receive benefit.
Why it matters
Potential benefit: If successful, the intervention could lower rates of emergence agitation and speed early postoperative recovery, potentially shortening PACU stays and reducing patient distress.
How similar studies have performed: Some prior small studies and perioperative protocols suggest verbal reorientation or environmental cues can reduce agitation or delirium, but the evidence is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult patients * Aged 18 to 70 years * Scheduled to undergo elective laparoscopic abdominal surgery will be screened for eligibility. Exclusion Criteria: * Include TIVA and inhalational agent other than sevoflurane, American Society of Anesthesiologists (ASA) physical status 4, * BMI \>35 kg/m\^2, * Pre-existing conditions associated with neurological deficit, * Cognitive impairment if documented by neurologist * Hearing disorders * Use of antipsychotic medications, * Plan for ambulatory surgery and participant refusal.
Where this trial is running
Lahore, Punjab Province
- Skmch & Rc — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Muhammad Imran, Post graduation resident
- Email: imranhaider@skm.org.pk
- Phone: 0304-3662943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.