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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Other: Orientation reminder

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Imran, Post graduation resident; Phone Number: 0304-3662943; Email: imranhaider@skm.org.pk
• Study Contact Backup: Name: Dr. Saad ur Rehman, Consultant; Phone Number: 0343-4545963; Email: saadurrehman@skm.org.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 042
      • Recruiting
      • Skmch & Rc
      • Contact: Dr. Farah Asif, MBBS; Phone Number: 4280 042-35905000; Email: crc3@skm.org.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3 including their name, the hospital name, and instructions to open their eyes , your operation has; Orientation group	Other: Orientation reminder; Orientation reminder will be given in the language which can understand by patient.
Other: Patients in the control group will not receive any additional verbal stimulation during emergence ap; Control group	Other: Orientation reminder; Orientation reminder will be given in the language which can understand by patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of emergence agitation in OR	Emergence agitation will be evaluated according to Riker Sedation Agitation Scale. Maximum SAS score will be considered for primary outcome.	5-10 minutes

Collaborators and Investigators

• Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
• Investigators: Study Chair: Dr AhsUn Waqar, Consultant, Skmch & Rc

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Emergence Agitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: IRB-24-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not specify.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No