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NCT Number: NCT05161780

Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation

This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma.

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Key information

Conditions

Irrigation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

About this study

The aims of this study are to determine whether the endoscopic surgical view is objectively clearer using Normal Saline versus Lactated Ringer's Irrigation during endoscopic skull base surgery for pituitary adenoma. Other objectives include determining whether lactated Ringer's irrigation decreases total estimated blood loss and whether use of lactated Ringer's irrigation shortens surgical time.

Hot saline irrigation at 40 degrees Celcius has been shown to improve endoscopic surgical field clarity and its use is common practice in both endoscopic inflammatory sinus surgeries and skull base procedures. Saline irrigation dilutes blood in the surgical field keeping the endoscopic view clean and more bloodless and the elevated temperature promotes hemostasis.

Preliminary evidence suggests that the use of calcium-containing irrigant may further improve endoscopic surgical views. This mechanism is thought to be mediated through the activation of platelets and providing a calcium source to calcium-dependent factors in the coagulation cascade thereby promoting hemostasis. Using lactated Ringer's, a calcium-containing fluid, may result in improved surgeon visualization, decreased blood loss, and decreased complications during endoscopic approaches to the skull base.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient with a primary pituitary adenoma, macro or micro adenoma.

Exclusion criteria

  • Age <18
  • Pregnancy
  • Revision surgery
  • Non-surgical candidate due to medical, surgical, or anesthesia contraindications

Treatment and study plan

Lactated Ringer's Irrigation

Drug

Lactated Ringers at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.

normal saline

Drug

Normal Saline at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.

Primary outcomes

  1. Boezaart scale rating video clips

    Time frame: 10 minutes

    Rating for each of the three recorded video clips per patient following tumor ablation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.

  2. Boezaart scale rating video clips

    Time frame: 10 minutes

    rating for each of the three recorded video clips per patient after 10 minutes of irrigation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.

  3. Boezaart scale rating video clips

    Time frame: 10 minutes

    rating for each of the three recorded video clips per patient at the completion of hemostasis. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection..

  4. Time

    Time frame: 10 minutes

    Time between tumor ablation and the completion of hemostasis, or total irrigation time for patients undergoing normal saline or Lactated Ringer's irrigation during their surgical case.

Secondary outcomes

  1. Estimated Blood Loss (EBL)

    Time frame: 15 min

    (EBL) per case and total operative time

Sponsors and collaborators

Lead sponsor

Carl Snyderman

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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