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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02325648
Enrollment
22
Registered
2014-12-25
Start date
2014-12-31
Completion date
2016-04-30
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Surface Malignancies

Brief summary

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.

Interventions

DRUGHIPEC 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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Vital signfrom 30 minutes to 90 minutes after HIPEC
Body temperaturefrom 30 minutes to 90 minutes after HIPEC
serum glucosefrom 30 minutes to 90 minutes after HIPEC
pulmonary vascular permeability indexfrom 30 minutes to 90 minutes after HIPEC

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026