Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
Condition: Brain Neoplasm
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Several modalities have been studied to prevent coughing during emergence, including
      extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no
      reliable method is recommended as standard of care. The advantages of administering tramadol
      includes a long duration of action, rapid recovery, limited depression of respiratory
      function and no effect on platelet makes it a safe medication to use for neurosurgical
      patients after craniotomy. The primary objective of the study is to observe the effect of
      single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic
      response (measurement of B.P and H.R) during extubation.
    

Detailed description: 
      Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis
      of intracranial complications. Extubation however, may be associated with haemodynamic and
      metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion,
      hypercapnia and systemic hypertension.

      These changes cause cerebral hyperemia, intracranial hypertension leading to cerebral oedema
      or haemorrhage, thus it is important to have smooth extubation with minimal haemodynamic and
      metabolic effects.

      Incidence of coughing on emergence from general anesthesia ranges from 38% to 96%. This may
      also result in postoperative intracranial hemorrhage, intracranial hypertension, cerebral
      edema or intraocular hypertension.This can be detrimental in neurosurgery.

      Several modalities have been studied to prevent coughing during emergence, including
      extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no
      reliable method is recommended as standard of care.

      Tramadol, a synthetic opioid of the aminocyclohexanes group, is a centrally acting opioid
      analgesic that is used to treat moderate-to-severe pain and has an inhibitory effect on M1
      and M3 muscarinic receptors. It also reduces the incidence of cough and improves extubation
      quality, and provides more stable haemodynamics during emergence. It neither causes
      respiratory depression, nor affects intracranial pressure (ICP) and cerebral perfusion
      pressure (CPP). Other potential advantage of administering tramadol includes a long duration
      of action, rapid recovery, limited depression of respiratory function and no effect on
      platelets thus making it a safe medication to use for neurosurgical patients after
      craniotomy. The onset of effect following a single dose is 3 to 5 minutes with peak effect at
      45 minutes.

      Aim of doing this study is to observe the effect of a single dose of tramadol on quality of
      tracheal extubation as judged by incidence of coughing and haemodynamic changes at emergence
      from anesthesia.

      OBJECTIVE:

      Primary Objective: To observe the effect of single dose of tramadol (1mg/kg) administered 45
      minutes before extubation on haemodynamic response (measurement of B.P and H.R) during
      extubation.

      Secondary Objective: To measure the quality of emergence from general anaesthesia by
      measuring the frequency of cough, laryngospasm and episodes of desaturation.

      OPERATIONAL DEFINITION:

      Emergence Period: This will be defined as the time from the recovery of spontaneous breathing
      after giving reversal to tracheal extubation.

      Quality of emergence: Good quality emergence will be defined as extubation not associated
      with coughing, bucking, tachycardia, hypertension, laryngospasm or bronchospasm.

      Tachycardia and hypertension: Rise in heart rate and blood pressure more than 20% from
      baseline value.

      Extubation response: Physiological response related to blood pressure and heart rate during
      extubation of trachea is called extubation response,

      HYPOTHESIS:

      Tramadol obtunds haemodynamic and cough response to extubation and thus results in good
      quality emergence after supratentorial craniotomy.
    

Intervention name(s): Injection Tramadol; placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.9% Normal saline in 10 ml syringe
Other intervention name(s): Tramal; normal saline
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: supratentorial craniotomy; extubation response; emergence; tramadol