Health TrialsbyHealthPanel

Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

ConditionsAwakeThoracic Epidural AnesthesiaGeneral AnesthesiaThoracotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCairo University

About this trial

This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 75 years old.

Both genders.

American Society of Anesthesiologists (ASA) physical status classification II or III.

Scheduled for thoracotomy.

Disqualifiers

Difficult airway management,

Hemodynamically unstable patients, obesity (body mass index >30).

Absolute contraindication to thoracic epidural anesthesia such as (patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural).

Neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain edema, extensive pleural adhesions or previous pulmonary resections, hypoxemia (PaO2 <60) or hypercarbia (PaCO2 >50)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Awake thoracic epidural anesthesia

    Drug

    Patients will preoperatively receive awake thoracic epidural anesthesia.

  • General anesthesia

    Drug

    Patients will receive general anesthesia.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Awake thoracic epidural anesthesia groupExperimental treatment 1 intervention
Group B: General anesthesia groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assessment the change in pulmonary function

The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.

Time frame
24 hours postoperatively

Secondary outcomes

1

Heart rate

Heart rate will be recorded at baseline, and every 15min till the end of surgery.

Time frame
Till the end of surgery (Up to 2 hours)
2

Mean arterial pressure

Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery.

Time frame
Till the end of surgery (Up to 2 hours)
3

Degree of pain

The patients will be instructed how to report pain by means of the visual analogue scale (VAS), in which 0 = "no pain" and 10 = "worst possible pain". VAS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12,18, 24, 36, 48 hours postoperative.

Time frame
48 hours postoperatively
4

Total morphine consumption

Rescue analgesia of morphine will be given as 3 mg bolus if the VAS \> 3 to be repeated after 30 min if pain persists until the visual analogue scale (VAS) \< 4.

Time frame
48 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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