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Completed

NCT Number: NCT04443946

Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

This prospective open-label randomized study, patients were having elective urological surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xuanwu hospital

Beijing, Beijing Municipality, 100053, China

About this study

Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase. Due to the ethical requirements of adequent analgesia, 0.3 μ g kg-1 min-1 remifentanil was continuously pumped as background input dose during anesthesia maintenance in all groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the aged 18-65 yr,
  • ASA physical status I, II or III patients
  • having elective urological surgery
  • operation scheduled to last longer than 1 h
  • under necessitating general anesthesia

Exclusion criteria

  • refused to participate in the study;
  • were not able to communicate due to alterations in the level of consciousness, - a history of allergy to opioids
  • contraindications inhalational anaesthesia
  • family history of malignant hyperthermia
  • alcohol or drug abuse
  • received central nervous system-active drugs;
  • body mass index ≥40 kg/m2
  • represent conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
  • previous head injury, neurologic or psychiatric disease
  • any disabling central nervous
  • cerebrovascular disease
  • current use of psychoactive or anti-convulsive medications
  • unstable angina
  • manifest congestive heart failure
  • airway management was expected to be difficult

Treatment and study plan

Propofol

Drug

5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

1% Sevoflurane

Drug

add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.

1% Sevoflurane continue

Drug

1% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Other names: 1% Sevoflurane

Sufentanil

Drug

0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

2% Sevoflurane

Drug

2% sevoflurane continued to maintain anesthesia after endotracheal intubation.

Other names: 2% Sevoflurane continue

Propofol half

Drug

2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Other names: 2.5% Propofol

Primary outcomes

  1. Extubation Duration(ED)

    Time frame: Up to 24 hours

    the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA

Secondary outcomes

  1. Length of PACU

    Time frame: Up to 24 hours

    Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU

  2. qNOX

    Time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

    Noceciption index,The qNOX of depth of analgesia also ranges from 99 to 0, and usually it is controlled to be within 40-60 during the operative period, with qNOX > 80 indicating an insufficient use of analgesic agents and qNOX < 10 indicating excessive analgesic effects.

  3. Bis

    Time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

    Bispectral index,Bis 50-80 means appropriate Sedation depth

  4. Blood pressure

    Time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

    measuring Systolic, Diastolic and Mean Blood Pressure

  5. The heart rate

    Time frame: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

    The heart rate

Sponsors and collaborators

Lead sponsor

China International Neuroscience Institution

Other

Registry information

Official study title

Different Anesthesia Maintain Protocol Effect the Outcome of the Patients Undergoing General Anesthesia for Urinary Surgery

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Oct 14, 2020

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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