An interventional study of Thoracic Spinal Anesthesia and Thoracic Epidural Anesthesia in Nephrectomy, Lung Diseases and Anesthesia, sponsored by Nazmy Edward Seif. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Nazmy Edward Seif · Not applicable, Interventional, and Supportive care
Patients with respiratory disease have an increased risk of developing complications perioperatively. The use of regional anesthesia decreases this risk with better postoperative outcome. The aim of this study is to compare the safety and efficacy of thoracic spinal versus thoracic epidural anesthesia for open nephrectomy in patients with obstructive/restrictive lung disease.
1,158 studies on the registry are indexed under Lung Diseases; 182 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 663 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Nazmy Edward Seif is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Thoracic Spinal Anesthesia; Bupivacaine 0.5% (hyperbaric) 7.5mg, Fentanyl 25 µg \& Dexmedetomidine 5 µg by intrathecal injection
Procedure: Thoracic Spinal Anesthesia · Drug: Bupivacaine 0.5% (hyperbaric) · Drug: Fentanyl · Drug: Dexmedetomidine
Thoracic Epidural Anesthesia; Bupivacaine 0.5% (isobaric) 25-50 mg \& Fentanyl 10-20 µg by epidural injection
Procedure: Thoracic Epidural Anesthesia · Drug: Bupivacaine 0.5% (isobaric) · Drug: Fentanyl
Spinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany). When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) \& 5 μg dexmedetomidine will be injected.
Epidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the "Prefix Custom Epidural Anesthesia Tray" with an 18 G Tuohy epidural needle \& a 20 G epidural catheter. Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose \& continued throughout the procedure.
Neuro-axially injected
Also known as: Heavy Marcaine
Neuro-axially injected
Also known as: Marcaine
Neuro-axially injected
Neuro-axially injected
Patient Satisfaction Score
Patient Satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent "E" (best score), fair "F" \& poor "P" (worst score).
Time frame: 24 hours
VAS
Visual Analogue Score for pain graded from 0-10 \[0: no pain, 10: worst pain\].
Time frame: 12 hours
Mean ABP
Change in Mean Arterial Blood Pressure measured in mmHg.
Time frame: 12 hours
Plan to share: Undecided
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bupivacaine · Dexmedetomidine
Nazmy Edward Seif