Clinical Trial: Effect of Dexmedetomidine on Stress Response and Emergence Agitation During Laparoscopic Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Different Doses of Dexmedetomidine on Stress Response and Emergence Agitation After Laparoscopic Cholecystectomy in Adults

Brief Summary:

Emergence agitation is a post-anesthetic phenomenon that develops in the early phase of general anesthesia recovery, and is characterized by agitation, confusion, disorientation, and possible violent behavior. The incidence of emergence agitation is less common in adults as compared to pediatric patients. It may lead to serious consequences for the patient such as bleeding, falling, removal of catheters and self extubation, which lead to further complications like hypoxia and aspiration.

Despite its common occurrence, unclear etiology, and serious sequelae, emergence agitation has rarely been studied in adults.

The stress response to surgery is an unconscious response to tissue injury. Activation of the sympathetic nervous system, increase of catabolic hormone release and pituitary gland suppression are considered a response to surgical stress, in clinical practice these activities cause changes in heart rate, blood pressure and biochemical fluctuations of noradrenaline, adrenaline, dopamine, and cortisol. Above all, these fluctuations prolong hospitalization and delay patients discharge.

Dexmedetomidine is a highly selective alpha-2 receptor agonist having sedative, analgesic and sympatholytic properties. Decreased stress response to surgery ensuring a stable hemodynamic state is a beneficial property of the agent. Peri-operative use of dexmedetomidine also decreases postoperative opioid consumption, pain intensity, and antiemetic therapy. However, the data related to the effects of dexmedetomidine on reducing agitation from general anesthesia in adults are limited.


Detailed Summary:

With no premedication, all patients will have pre-oxygenation for 3-5 minutes and intravenous access will be secured. NaCl 0.9% 4 ml/kg/h will be infused intraoperatively. General anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg and nimbex (cisatracurium) 0.15 mg/kg. Endotracheal intubation then will be done using oral ETT of appropriate size under direct laryngoscopy and secured at the angle of the mouth. Sevoflurane inhalational anesthetic (2-4 %) and nimbex 0.03 mg/kg will be used for maintenance of anesthesia. The lungs will be mechanically ventilated to keep intra-operative EtCo2 between 35-40 mmHg.

Intraoperative monitoring:

Routine monitors including ECG, non-invasive blood pressure, pulse oxymetry and EtCo2 will be recorded every 5 minutes during the intra-operative 20 minutes of the study drug administration. Bradycadia (heart rate ˂ 60 beat/minute) will be treated with iv atropine 0.5 mg. Hypotension (mean arterial blood pressure ˂ 60 mmHg) will be treated with iv ephedrine 5 mg increments. Duration of anesthesia, sevoflurane % and duration of surgery will be recorded.

At the end of surgery and stoppage of sevoflurane inhalation, neostigmine 0.04 mg/kg and atropine 0.02 mg/kg will be used for muscle relaxant reversal (Time 0 in the emergence process), patients will be extubated and transferred to the PACU for recovery and monitoring.

Assessment in PACU:

Routine monitoring will be continued during staying in PACU. During emergence, the level of agitation will be evaluated using the Ricker sedation-agitation scale (RSAS). The maximum level of agitation will be recorded for each patient at time 0, 5, 10, 20, 30, 60 and 120 minutes. Emergence a
Sponsor: Assiut University

Current Primary Outcome: serum cortisol level [ Time Frame: 2 hours postoperative ]

serum cortisol level will be measured at 2 hours postoperative


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • post anesthetic emergence agitation [ Time Frame: 2 hours postoperative ]
    RSAS score will be measured 2 hours postoperative
  • visual analogue score [ Time Frame: 24 hours postoperative ]
    perfalgan will be given when visual analogue score ≥ 4


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: September 5, 2016
Date Started: May 2016
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017