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The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study

NCT ID: NCT02325648

Last Updated: 2016-11-02

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

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

Brief Summary

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The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.

Detailed Description

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Conditions

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Peritoneal Surface Malignancies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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HIPEC cytoreductive surgery

HIPEC cytoreductive surgery

Intervention Type DRUG

At least 30 minutes prior to the prospective conclusion of the surgery, 1 μg/kg of fentanyl is administered for postoperative analgesia and 0.075mg of palonosetron is IV-infused for the prevention of nausea and vomiting. Desflurane and remifentanil administration is ceased after the surgery is concluded, muscle relaxation is evaluated by train of four (TOP) monitoring using a nerve stimulator, and the neuromuscular blockade is reversed with 0.2 mg of glycopyrrolate and 1 mg of neostigmine. When the patient recovers consciousness and begins spontaneous respiration, extubation is performed and the patient is transferred to the ICU with monitoring of their vital signs.

Interventions

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HIPEC cytoreductive surgery

At least 30 minutes prior to the prospective conclusion of the surgery, 1 μg/kg of fentanyl is administered for postoperative analgesia and 0.075mg of palonosetron is IV-infused for the prevention of nausea and vomiting. Desflurane and remifentanil administration is ceased after the surgery is concluded, muscle relaxation is evaluated by train of four (TOP) monitoring using a nerve stimulator, and the neuromuscular blockade is reversed with 0.2 mg of glycopyrrolate and 1 mg of neostigmine. When the patient recovers consciousness and begins spontaneous respiration, extubation is performed and the patient is transferred to the ICU with monitoring of their vital signs.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital

Exclusion Criteria

* Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, South Korea, South Korea

Site Status

Countries

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South Korea

References

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Kim MH, Yoo YC, Bai SJ, Lee KY, Kim N, Lee KY. Physiologic and hemodynamic changes in patients undergoing open abdominal cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. J Int Med Res. 2021 Jan;49(1):300060520983263. doi: 10.1177/0300060520983263.

Reference Type DERIVED
PMID: 33445991 (View on PubMed)

Other Identifiers

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4-2014-0854

Identifier Type: -

Identifier Source: org_study_id