Spine Fracture Clinical Trial
Official title:
Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery, Randomized Double Blinded Clinical Trial
Reduction of intra-operative blood loss
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | March 30, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age 18- 65 years. - American Society of Anesthesiologists physical status classification (ASA) I - III - Patients scheduled for posterior lumbar interbody fusion (2-level or 3-level). Exclusion Criteria: - Urgent or emergency case or re-operation. - History of pre-operative anticoagulant medication or an indication for peri-operative anticoagulant medication. - ASA classification more than III. - Age less than 16 years. - Reduced left and right ventricular function (ejection fraction <40%). - Previous respiratory disease or a diagnosed neuromuscular disorder. - Pre-operative dysrhythmia. - Allergy to neuromuscular blocking agents. - Family history of malignant hyperthermia. - Decreased renal function (serum creatinine level more than twice the normal range, urine output <0.5 ml kg/h, glomerular filtration ratio <60 ml/ h). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094. — View Citation
Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380. Review. — View Citation
Hatada T, Kusunoki M, Sakiyama T, Sakanoue Y, Yamamura T, Okutani R, Kono K, Ishida H, Utsunomiya J. Hemodynamics in the prone jackknife position during surgery. Am J Surg. 1991 Jul;162(1):55-8. — View Citation
Kang WS, Oh CS, Rhee KY, Kang MH, Kim TH, Lee SH, Kim SH. Deep neuromuscular blockade during spinal surgery reduces intra-operative blood loss: A randomised clinical trial. Eur J Anaesthesiol. 2020 Mar;37(3):187-195. doi: 10.1097/EJA.0000000000001135. — View Citation
Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920. — View Citation
Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15. — View Citation
Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13. — View Citation
Wadsworth R, Anderton JM, Vohra A. The effect of four different surgical prone positions on cardiovascular parameters in healthy volunteers. Anaesthesia. 1996 Sep;51(9):819-22. — View Citation
Yokoyama M, Ueda W, Hirakawa M, Yamamoto H. Hemodynamic effect of the prone position during anesthesia. Acta Anaesthesiol Scand. 1991 Nov;35(8):741-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Volume of surgical bleeding. | Volume of surgical bleeding will be recorded before surgical field lavage, and again at the end of surgery, by measuring the total volume of blood collected in the suction bottle minus the lavage fluid volume used for wound irrigation. | Baseline | |
Secondary | surgeon's satisfaction with the operating conditions | The score for the surgeon's satisfaction (lowest, 1; highest, 5) with the surgical conditions will be assessed at the end of surgery. Extremely poor (Score 1) indicated that the surgeon is unable to work because of an inability to obtain a visible field due to inadequate muscle relaxation; poor (Score 2) indicated that there is a visible field, but the surgeon is severely hampered by inadequate muscle relaxation; acceptable (Score 3) indicated that there is a wide visible field and acceptable muscle relaxation; good (Score 4) indicated a wide working field with adequate muscle relaxation; excellent (Score 5) indicated a wide visible working field without any muscle rigidity. | Baseline |
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