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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShaukat Khanum Memorial Cancer Hospital & Research Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 70 years

Scheduled to undergo elective laparoscopic abdominal surgery will be screened for eligibility.

Disqualifiers

Include TIVA and inhalational agent other than sevoflurane, American Society of Anesthesiologists (ASA) physical status 4,

BMI >35 kg/m²,

Pre-existing conditions associated with neurological deficit,

Cognitive impairment if documented by neurologist

Trial design

Design model

Parallel

Treatments tested in this trial

  • Orientation reminder

    Other intervention

    Orientation reminder will be given in the language which can understand by patient.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: 3 including their name, the hospital name, and instructions to open their eyes , your operation hasOther 1 intervention
Group B: Patients in the control group will not receive any additional verbal stimulation during emergence apOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5-10 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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