Comparing Sevoflurane With Propofol Sedation in ESRF Patients

NCT04839536 | Unknown Phase 4 FDA Drug

• 1 other identifier: MREC: 2021116-9722
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

End-stage renal failure (ESRF) cohorts undergo brachiocephalic fistula(BCF) transposition with supraclavicular block. However, this is inadequate because the incision may extend to the axillary region which requires intercostobrachial (T2) dermatome blockage. Sedation is commonly indicated to allay anxiety whilst allowing intraprocedural lignocaine infiltration. It is challenging to administer safe sedation to ESRF patients due to multiple comorbidities, polypharmacy, altered pharmacokinetic drug handling. Intraoperative hypotension can be common and evident from the residual effect of antihypertensive and intravascular hypovolemia from regular hemodialysis. Midazolam is metabolized to an active metabolite which can accumulate causes apnea and delayed recovery. TCI propofol needs higher induction doses to achieve hypnosis causes exaggerated hypotension which may jeopardize organ perfusion. The investigators are exploring the potential benefit of sevoflurane sedation which are independent of renal clearance, rapid onset and offset, and ischemic preconditioning property in ESRF cohorts.

Conditions

Sevoflurane; Kidney Diseases; Procedural Hypotension

Keywords

Sevoflurane Sedation, ESRF

Outcome Measures

Primary Outcomes (1)

• Change in mean arterial pressure from baseline following sedation

  Hemodynamic instability is defined as event below: Hypotension- Drop in mean arterial pressure (MAP) from baseline by more than 20% Hypotension - Drop in systolic blood pressure (sBP \< 140 mmHg) and diastolic blood pressure (dBP \< 90 mmHg)

  At baseline, pre-, and immediately after intervention

Secondary Outcomes (3)

• Number of hemodynamic interventions required during sedation

  At baseline, pre-, and immediately after intervention

• Duration of hemodynamic instability

  At baseline, pre-, and immediately after intervention and surgery

• Onset time and recovery time

  At baseline, pre-, and immediately after intervention and surgery

Study Arms (2)

Target controlled infusion (TCI) propofol

ACTIVE COMPARATOR

For TCI propofol group, all patients will receive nasal CPAP mask and nasal breathing with oxygen of 3 litre/min. We will utilize the Schneider model to target effect-site (Cet) starting from 0.5 mcg/ml and with a gradual 0.5mcg/ml increment every 30s until OAAS score of 3 is achieved. For any patients with OAAS score \< 3, Cet will be decreased by a decremental 0.5 mcg/ml. The deepest level of sedation will be recorded.

Drug: Sevoflurane inhalant product

Sevoflurane sedation

EXPERIMENTAL

Patients randomised to this arm will be given time to familiarise with the nasal continuous positive airway pressure (CPAP) mask and nasal breathing with oxygen 3 litre/min via a Bain anaesthetic circuit before the introduction of sevoflurane. Once the patient starts to adapt to nasal CPAP mask, sevoflurane will be delivered, starting with a concentration of 0.2% and increase stepwise by 0.2% every 30s until sedation score of OAAS of 3 is achieved. Anaesthetist in charge will assess and maintain sedation endpoint to OAAS 3. If patient is over sedated, sevoflurane concentration will be reduced by 0.2% until OAAS 3. The deepest level of sedation will be recorded.

Drug: Sevoflurane inhalant product

Interventions

Sevoflurane inhalant product DRUG

Sevoflurane will be delivered in an incremental dose to throughout procedure to achieve clinical sedation endpoint OAAS 3.

Also known as: Ultane, 74412392

Sevoflurane sedation; Target controlled infusion (TCI) propofol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with end stage renal failure, dialysis dependent undergoing transposition of brachiocephalic fistula repair
• American Society of Anesthesiology Physical Status Classification System (ASA) II or III

You may not qualify if:

• Patient refusal
• History or family history of malignant hyperthermia
• Known allergy to propofol or local anaesthetic agent
• Patients who have taken neuroleptics, benzodiazepine over 2 weeks within 1 month
• Chronic use of alcohols/ opioid
• Active lungs disease (eg. acute exacerbation of chronic obstructive pulmonary disease)
• Active and significant cardiac disease (eg. decompensated congestive cardiac failure, recent myocardial infarction)
• End-stage heart failure with left ventricular ejection fraction \< 30%
• Recent (\< 3 months) cerebrovascular accident

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (8)

• Quek KH, Low EY, Tan YR, Ong ASC, Tang TY, Kam JW, Kiew ASC. Adding a PECS II block for proximal arm arteriovenous access - a randomised study. Acta Anaesthesiol Scand. 2018 May;62(5):677-686. doi: 10.1111/aas.13073. Epub 2018 Jan 22.

  PMID: 29359313 BACKGROUND

• Rutkowska K, Knapik P, Misiolek H. The effect of dexmedetomidine sedation on brachial plexus block in patients with end-stage renal disease. Eur J Anaesthesiol. 2009 Oct;26(10):851-5. doi: 10.1097/EJA.0b013e32832a2244.

  PMID: 19550340 BACKGROUND

• Virmani S, Onuchic A, El-Ali IM, Trivedi RD. Propofol Induced Hyperkalemia and Its Management in End Stage Renal Disease Patients. Conn Med. 2016 Sep;80(8):491-493.

  PMID: 29782787 BACKGROUND

• Zhong W, Zhang Y, Zhang MZ, Huang XH, Li Y, Li R, Liu QW. Pharmacokinetics of dexmedetomidine administered to patients with end-stage renal failure and secondary hyperparathyroidism undergoing general anaesthesia. J Clin Pharm Ther. 2018 Jun;43(3):414-421. doi: 10.1111/jcpt.12652. Epub 2017 Dec 16.

  PMID: 29247451 BACKGROUND

• Xie X, Atkins E, Lv J, Bennett A, Neal B, Ninomiya T, Woodward M, MacMahon S, Turnbull F, Hillis GS, Chalmers J, Mant J, Salam A, Rahimi K, Perkovic V, Rodgers A. Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. Lancet. 2016 Jan 30;387(10017):435-43. doi: 10.1016/S0140-6736(15)00805-3. Epub 2015 Nov 7.

  PMID: 26559744 BACKGROUND

• Maheshwari K, Ahuja S, Khanna AK, Mao G, Perez-Protto S, Farag E, Turan A, Kurz A, Sessler DI. Association Between Perioperative Hypotension and Delirium in Postoperative Critically Ill Patients: A Retrospective Cohort Analysis. Anesth Analg. 2020 Mar;130(3):636-643. doi: 10.1213/ANE.0000000000004517.

  PMID: 31725024 BACKGROUND

• James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.

  PMID: 24352797 BACKGROUND

• Kim HY, Lee JE, Kim HY, Kim J. Volatile sedation in the intensive care unit: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Dec;96(49):e8976. doi: 10.1097/MD.0000000000008976.

  PMID: 29245269 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Chao Chia Cheong, MMed Master

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Chia Cheong, MMed Master

CONTACT

+60163113597; chaochia@um.edu.my

Chew Yin Y Wang, FRCA

CONTACT

+60192340232; wangcy1836@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 9, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: Personal enquiry via email