Emergence Agitation
Conditions
Keywords
emergence agitation, gabapentin, nasal surgery
Brief summary
Emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. Emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . Furthermore, it may lead to injuries to health care providers and increase the demand on human resources. While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery . Gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. Gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . Gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting. A previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.
Interventions
DRUGGabapentin 600 mg capsules
21 patients will receive 600 mg oral gabapentin one hour before induction.
21 patients will receive 400 mg oral gabapentin one hour before induction.
DRUGPlacebo
21 patients will receive placepo one hour before induction.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Patients will be randomly allocated (using sealed opaque numbered envelopes indicating the group of each patient, carried out by an independent anesthesiologist) into one of three groups : * Group (A) \[n = 21 patients\]: will receive 600 mg oral gabapentin one hour before induction. * Group(B) \[n =21 patients \]:will receive 400 mg oral gabapentin one hour before induction. * Group (C) (control group) \[n =21 patients \] : will receive placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing elective nasal surgery will be eligible for the study.
Exclusion criteria
1. hypersensitivity to gabapentin 2. patient refusal 3. epilepsy 4. neurological or psychological conditions that impair communication. 5. current use of gabapentin, psychotropic or opioids medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asessment of emergence agitation | through study completion, an average of 1 year | Asessment of emergence agitation by Richmond Agitation Sedation Scale(RASS) (score +1 or more) maximum value is +4 (combative) andminimum value is - (unarousable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Post Anesthesia Care Unit (PACU)stay | through study completion, an average of 1 year | the time in minutes from arrival to Post Anesthesia Care Unit (PACU) to discharge to ward |
| Number of patients had Postoperative pain | through study completion, an average of 1 year | Postoperative pain through Numerical Rating Scale (0 represents no pain and 10 represents worst possible pain) |
| Number of patients required postoperative opioids and total dose. | through study completion, an average of 1 year | — |
| Number of patients had postoperative nausea and vomiting (PONV). | through study completion, an average of 1 year | — |
| Duration of emergence | through study completion, an average of 1 year | The time in minutes from the discontinuation of anesthesia till the time of spontaneous eye opening or to verbal command |
| systolic, diastolic and mean arterial blood pressure | through study completion, an average of 1 year | systolic, diastolic and mean arterial blood pressure in millimeter of mercury (mmHg) will be recorded every 5 minutes till the end of operation. |
| Oxygen saturation | through study completion, an average of 1 year | Oxygen saturation in percentage will be recorded every 5 minutes till the end of operation. |
| Duration of extubation | through study completion, an average of 1 year | the time in minutes from discontinuation of the anesthetic to removal of endotracheal tube |
| 1. Heart rate | through study completion, an average of 1 year | heart rate in beat per minute (bpm) will be recorded every 5 minutes till the end of operation. |
Countries
Egypt
Contacts
Primary Contactmaged mobarak mobarak, assisstant lecturer
Backup ContactHebatallah Salah Abdelhamid, : Lecturer of anesthesia, ICU
Outcome results
None listed