Effects of Sevoflurane and Desflurane on Treg

NCT ID: NCT02559297

Last Updated: 2017-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-10

Study Completion Date

2017-06-03

Brief Summary

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This prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing Living Donor Kidney Transplant (LDKT).

Detailed Description

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All patients with end stage renal disease (ESRD) need renal replacement therapy, either dialysis or kidney transplantation. Dialysis, despite its effectiveness in prolonging ESRD patients' lives, is a burden. Successfulness in kidney transplantation will restore good quality of life in ESRD patients. However, one of the most important complications that lead to transplant failure is graft rejection. It is already known that the pathophysiology of the rejection is immune response. Recent evidence showed that regulatory T cell (Treg) plays a central role in preventing graft rejection by inhibiting recipient alloimmune response (1-3). Characterization of Treg numbers and/or functional changes under various conditions may lead to a new preventive measure and/or a novel therapeutic strategy for graft rejection.

Kidney transplantation is conducted under general anesthesia. Interestingly, several agents used in general anesthesia have also modulated immune functions (4-12). Although the effect of inhalation anesthetic agents on leukocyte count has been shown, the effect on Treg function has totally been unknown. Knowing the effects of inhalation agents on Treg numbers and functions will be beneficial to intraoperative management during transplant surgery, aiming toward reducing the risk of graft rejection in the future.

Conditions

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Transplant; Failure, Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sevoflurane

In sevoflurane arm (n=20) at the beginning after successful intubation, 2 L/min nitric oxide (N2O), 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O.

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Desflurane

In desflurane arm (n=20) at the beginning after successful intubation, 2 L/min N2O, 2 L/min O2, and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 MAC of desflurane in 50% O2 and 50% N2O.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of desflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Interventions

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Sevoflurane

After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Intervention Type DRUG

Desflurane

After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of desflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).

Intervention Type DRUG

Other Intervention Names

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Ultane Suprane

Eligibility Criteria

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Inclusion Criteria

* Patients receiving 1st living donor kidney transplantation

Exclusion Criteria

* Hyperacute graft rejection
* Pre-existing autoimmune or immunodeficiency diseases in recipients
* Receiving blood product during 24-h perioperative period
* Patient refuse to participate this study at any time point
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Arpa Chutipongtanate

Faculty Member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arpa Chutipongtanate, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand

Locations

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Ramathibodi Hospital

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Edozie FC, Nova-Lamperti EA, Povoleri GA, Scotta C, John S, Lombardi G, Afzali B. Regulatory T-cell therapy in the induction of transplant tolerance: the issue of subpopulations. Transplantation. 2014 Aug 27;98(4):370-9. doi: 10.1097/TP.0000000000000243.

Reference Type BACKGROUND
PMID: 24933458 (View on PubMed)

San Segundo D, Millan O, Munoz-Cacho P, Boix F, Paz-Artal E, Talayero P, Morales JM, Muro M, De Cos MA, Guirado L, Llorente S, Pascual J, Arias M, Brunet M, Lopez-Hoyos M. High proportion of pretransplantation activated regulatory T cells (CD4+CD25highCD62L+CD45RO+) predicts acute rejection in kidney transplantation: results of a multicenter study. Transplantation. 2014 Dec 15;98(11):1213-8. doi: 10.1097/TP.0000000000000202.

Reference Type BACKGROUND
PMID: 25083613 (View on PubMed)

Lopez-Hoyos M, Segundo DS, Fernandez-Fresnedo G, Marin MJ, Gonzalez-Martin V, Arias M. Regulatory T cells in renal transplantation and modulation by immunosuppression. Transplantation. 2009 Aug 15;88(3 Suppl):S31-9. doi: 10.1097/TP.0b013e3181af7b99.

Reference Type BACKGROUND
PMID: 19667959 (View on PubMed)

Zhang T, Fan Y, Liu K, Wang Y. Effects of different general anaesthetic techniques on immune responses in patients undergoing surgery for tongue cancer. Anaesth Intensive Care. 2014 Mar;42(2):220-7. doi: 10.1177/0310057X1404200209.

Reference Type BACKGROUND
PMID: 24580388 (View on PubMed)

Schneemilch CE, Hachenberg T, Ansorge S, Ittenson A, Bank U. Effects of different anaesthetic agents on immune cell function in vitro. Eur J Anaesthesiol. 2005 Aug;22(8):616-23. doi: 10.1017/s0265021505001031.

Reference Type BACKGROUND
PMID: 16119599 (View on PubMed)

Ji FH, Wang YL, Yang JP. Effects of propofol anesthesia and sevoflurane anesthesia on the differentiation of human T-helper cells during surgery. Chin Med J (Engl). 2011 Feb;124(4):525-9.

Reference Type BACKGROUND
PMID: 21362275 (View on PubMed)

Pirbudak Cocelli L, Ugur MG, Karadasli H. Comparison of effects of low-flow sevoflurane and desflurane anesthesia on neutrophil and T-cell populations. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):41-51. doi: 10.1016/j.curtheres.2012.02.005.

Reference Type BACKGROUND
PMID: 24653511 (View on PubMed)

Loop T, Dovi-Akue D, Frick M, Roesslein M, Egger L, Humar M, Hoetzel A, Schmidt R, Borner C, Pahl HL, Geiger KK, Pannen BH. Volatile anesthetics induce caspase-dependent, mitochondria-mediated apoptosis in human T lymphocytes in vitro. Anesthesiology. 2005 Jun;102(6):1147-57. doi: 10.1097/00000542-200506000-00014.

Reference Type BACKGROUND
PMID: 15915027 (View on PubMed)

Hisano T, Namba T, Hashiguchi-Ikeda M, Ito T, Hirota K, Fukuda K. Inhibition of E-selectin-mediated leukocyte adhesion by volatile anesthetics in a static condition. J Anesth. 2005;19(1):1-6. doi: 10.1007/s00540-004-0274-0.

Reference Type BACKGROUND
PMID: 15674507 (View on PubMed)

Koksoy S, Sahin Z, Karsli B. Comparison of the effects of desflurane and bupivacaine on Th1 and Th2 responses. Clin Lab. 2013;59(11-12):1215-20. doi: 10.7754/clin.lab.2013.120413.

Reference Type BACKGROUND
PMID: 24409654 (View on PubMed)

Kim WH, Jin HS, Ko JS, Hahm TS, Lee SM, Cho HS, Kim MH. The effect of anesthetic techniques on neutrophil-to-lymphocyte ratio after laparoscopy-assisted vaginal hysterectomy. Acta Anaesthesiol Taiwan. 2011 Sep;49(3):83-7. doi: 10.1016/j.aat.2011.08.004. Epub 2011 Sep 22.

Reference Type BACKGROUND
PMID: 21982167 (View on PubMed)

Zhou D, Gu FM, Gao Q, Li QL, Zhou J, Miao CH. Effects of anesthetic methods on preserving anti-tumor T-helper polarization following hepatectomy. World J Gastroenterol. 2012 Jun 28;18(24):3089-98. doi: 10.3748/wjg.v18.i24.3089.

Reference Type BACKGROUND
PMID: 22791944 (View on PubMed)

Chutipongtanate A, Prukviwat S, Pongsakul N, Srisala S, Kamanee N, Arpornsujaritkun N, Gesprasert G, Apiwattanakul N, Hongeng S, Ittichaikulthol W, Sumethkul V, Chutipongtanate S. Effects of Desflurane and Sevoflurane anesthesia on regulatory T cells in patients undergoing living donor kidney transplantation: a randomized intervention trial. BMC Anesthesiol. 2020 Aug 27;20(1):215. doi: 10.1186/s12871-020-01130-7.

Reference Type DERIVED
PMID: 32854613 (View on PubMed)

Other Identifiers

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04-58-23

Identifier Type: -

Identifier Source: org_study_id

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