Emergence AgitationNCT07510516
Effect of a Repeated Verbal Reminder of Orientation on Emergence Agitation After General Anesthesia
A study testing Orientation reminder in people with Emergence Agitation, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Orientation reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jan 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Aged 18 to 70 years
- Scheduled to undergo elective laparoscopic abdominal surgery will be screened for eligibility.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Skmch & Rc
Lahore, Punjab Province, 042
Dr. Farah Asif, MBBS, 042-35905000 ext. 4280, crc3@skm.org.pk
About this study
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.
Read the 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
- Being tested
- Orientation reminder
- Keywords
- Emergence Agitation
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orientation reminderOther
Orientation reminder will be given in the language which can understand by patient.
| Study group | Role | What they receive |
|---|---|---|
| 3 including their name, the hospital name, and instructions to open their eyes , your operation has | Other | Orientation group Receives: Other: Orientation reminder |
| Patients in the control group will not receive any additional verbal stimulation during emergence ap | Other | Control group Receives: Other: Orientation reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start29 Jan 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr AhsUn Waqar, Consultant, Study chair, SKMCH & RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510516
- Sponsor's protocol ID
- IRB-24-33
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not specify.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Repeated Verbal Reminder of Orientation on Emergence Agitation After General Anesthesia
- ClinicalTrials.gov ID
- NCT07510516
- Acronym / sponsor ID
- IRB-24-33
- Conditions
- Emergence Agitation
- Keywords
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 3 including their name, the hospital name, and instructions to open their eyes , your operation has | Other | Other: Orientation reminderOrientation group |
| Patients in the control group will not receive any additional verbal stimulation during emergence ap | Other | Other: Orientation reminderControl group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Aged 18 to 70 years
- Scheduled to undergo elective laparoscopic abdominal surgery will be screened for eligibility.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orientation reminderOrientation reminder will be given in the language which can understand by patient. | Other | 3 including their name, the hospital name, and instructions to open their eyes , your operation has, Patients in the control group will not receive any additional verbal stimulation during emergence ap |
Primary outcome
incidence of emergence agitation in OR
Time frame: 5-10 minutes
Emergence agitation will be evaluated according to Riker Sedation Agitation Scale. Maximum SAS score will be considered for primary outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. Not specify.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr AhsUn Waqar, Consultant study chair
SKMCH & RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orientation reminder in people with Emergence Agitation, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Imran, Post graduation resident (0304-3662943, imranhaider@skm.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of emergence agitation in OR (time frame: 5-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.