Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTongji Hospital

About this trial

Endoscopic sinus surgery (ESS) is a primary surgical approach for treating chronic rhinosinusitis, nasal polyps, and other conditions that are unresponsive to conservative therapy. A clear surgical field is a critical prerequisite for ensuring precision, efficiency, and the avoidance of injury to vital structures such as the orbit and the skull base. Currently, the anesthetic regimens commonly used for ESS include total intravenous anesthesia (TIVA), inhalational anesthesia (IA), and intravenous-inhalational combined anesthesia (IVIH). However, there remains controversy regarding the comparative effects of these three modalities on surgical field quality. IVIH, as an anesthetic strategy that integrates the advantages of both intravenous and inhalational agents, is widely employed in clinical practice. In the context of ESS, it may reduce the dose of individual agents through combination therapy, thereby minimizing dose-related adverse effects. Some studies have shown that propofol-based TIVA provides better surgical field conditions than inhalational anesthetics (e.g., desflurane, sevoflurane), but does not significantly reduce total blood loss or shorten operative time. Nevertheless, propofol is associated with drawbacks such as injection pain and propofol infusion syndrome. Fospropofol disodium, a water-soluble prodrug of propofol, offers a significant advantage in reducing injection pain and provides more stable hemodynamic profiles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-65 years

ASA physical status I-II

BMI 18-35 kg/m²

diagnosed with chronic rhinosinusitis (with or without nasal polyps) and scheduled for elective endoscopic sinus surgery

Disqualifiers

uncontrolled hypertension or asthma

use of medications that may affect coagulation function (e.g., NSAIDs) within 1 week prior to surgery

pre-existing coagulation abnormalities

history of bleeding disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fospropofol disodium

    Drug

    Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.

  • Propofol

    Drug

    Propofol induction and propofol maintenance with or without sevoflurane.

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: Group PActive comparator 1 intervention
Group B: Group FExperimental treatment 1 intervention
Group C: Group PSExperimental treatment 1 intervention
Group D: Group FSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The score of the Wormald scale

The Wormald scales was used to assess the quality of the surgical field, 0-10 points, with higher scores indicating worse visual field.

Time frame
From the start of surgery to the end of surgery
2

The score of the Boezaart scale

The Boezaart scales was used to assess the quality of the surgical field, 0-5 points, with higher scores indicating worse visual field.

Time frame
From the start of surgery to the end of surgery

Secondary outcomes

1

Total blood loss

Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery

Time frame
Perioperative
2

The rate of bleeding

Total blood loss divided by surgical duration

Time frame
Perioperative
3

Induction time

From the start of anesthesia to loss of consciousness

Time frame
Perioperative
4

Extubation time

From the end of anesthesia to extubation

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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