NCT07510516

Effect of a Repeated Verbal Reminder of Orientation on Emergence Agitation After General Anesthesia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The Study will be conducted at SKMCH \& RC Lahore. All adult patients aged 18-70 years scheduled to undergo elective laparoscopic abdominal surgery will be screened for eligibility according to inclusion \& exclusion criteria. Total number of patients is 42. Patients who meet eligibility criteria will be randomized into 2 groups, Orientation group \& Control group. In orientation group, orientation reminder will be given in the form of prerecorded voice notes via headphones to the patients. The evaluation of emergence agitation will be done by using Riker Sedation Agitation Scale. The primary outcome will be incidence of emergence agitation in the OR. Secondary outcome includes the time from sevoflurane discontinuation to eye opening, extubation, discharge to PACU as well as pain score and length of stay in the PACU.

Detailed description

The proposed research study will be conducted at Shaukat Khanum Memorial Hospital, Lahore, and will be approved by the Institutional Review Board of the hospital. Additionally, the study will be registered prospectively with a recognized clinical trials registry. Duration: Until the recruitment of all subjects. We aimed to evaluate the effectiveness of repeated verbal reminder of orientation in reducing emergence agitation and improving postoperative recovery outcomes after general anesthesia in our patients at Shaukat Khanum Memorial Hospital, Lahore. Our hypothesis posits that emergence agitation will occur less frequently in patients aged 18 to 70 years, undergoing general anesthesia for abdominal surgery, who receive repeated verbal orientation information compared to those who only hear their own names. Patients who meet the eligibility criteria will be randomized into two groups: the orientation group and the control group. Randomization will be performed using a computer-generated sequence in a 1:1 ratio. Allocation will be concealed using sealed opaque envelopes. The randomization process will be overseen by an independent investigator not involved in the outcome assessment. A day before the surgery, patients will undergo preoperative assessment by an investigator and will be provided with information regarding the anesthesia protocol. Standard monitoring will be initiated upon entry into the operating room, including electrocardiography, pulse oximetry, temperature probe, and end-tidal carbon dioxide monitoring. General anesthesia will be induced with propofol and fentanyl, and neuromuscular blockade will be achieved with atracurium in both groups. Anesthesia will be maintained with sevoflurane in both groups. Prophylactic antiemetics and analgesics will be administered as per standard practice. In the orientation group,, orientation reminders will be given in the form of prerecorded voice notes via headphones to the patient, starting from the point when MAC is 0.3 including their name, the hospital name, and instructions to open their eyes , your operation has successfully done now you are recovering from general anesthesia and will be repeated every 5 seconds until the opening of the eyes. Patients in the control group will not receive any additional verbal stimulation during emergence apart from patients' names and instructions to open their eyes. No tactile stimulation will be provided during emergence For evaluation of emergence agitation, the Riker sedation agitation scale (SAS) will be used. This scale will be applied to calculate the SAS score from the point when MAC is 0.3 to discharge of patient from OR every 5 minutes. The maximum SAS score will be considered Primary outcome. The primary outcome was the incidence of emergence agitation in the OR. If Riker sedation agitation scale score will be 4 or less than 4 then it will be considered non-agitated and if will be more than 4 then will be considered agitated. Secondary outcomes will include the time from sevoflurane discontinuation to eye opening, extubating, and discharge to PACU, as well as pain scores, and length of stay in the PACU. Also details of any regional anesthesia would be noted down to account for potential confounding factors.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
OTHER	Orientation reminder	Orientation reminder will be given in the language which can understand by patient.

Timeline

• Start date: 2025-01-29
• Primary completion: 2026-07-31
• Completion: 2026-10-30
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Pakistan