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Comparison of the effect of laryngeal mask and tracheal tube on hemodynamic response, recovery time and intraocular pressure in cataract surgery of elderly with high blood pressure, a randomized clinical trial study

Comparison of the effect of laryngeal mask and tracheal tube on hemodynamic response, recovery time and intraocular pressure in cataract surgery of elderly with high blood pressure, a randomized clinical trial study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240721062497N1
Enrollment
100
Registered
2024-10-23
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Before inserting the airway device, immediately and 5 minutes after inserting the device and finally in the recovery room, hemodynamic status including systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation, respiration rate and intraocular pressure (IOP) are measured. . The duration of intubation, the total duration of surgery and the length of stay in recovery are also recorded for patients in two groups of laryngeal mask and tracheal tube..

Interventions

Intervention 1: Intervention group: LMA group, in this group, in the initial stage and before the surgery, basic and demographic characteristics are recorded for each patient. Then IV line is taken fo
is measured. Intervention 2: Control group: tracheal tube, in the tracheal tube group, the same procedures are performed as in the LMA group.

Sponsors

Shahroud University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age over 60 years- Requires cataract surgery based on the diagnosis of a specialist doctor- Entry of people with controlled blood pressure (119)Glaucoma in the eye- According to the classification system of the American Society of Anesthesiologists (ASA), the patient should be classified as PS2. The American Society of Anesthesiology classifies patients into 6 classes based on their physical condition and independent of the surgical method: PS1: Patients with normal health who do not have any systemic problems such as cardiac, vascular, respiratory, endocrine, etc. PS2: A person who has a mild systemic disease and the disease is under control and has not created any restrictions for the patient. PS3: A person who has a severe systemic disease and functional limitations have been created for him. PS4: A disease that has a severe systemic disease and puts the person's life at risk. PS5: A patient who is dying and is not expected to survive without surgery. PS6: A patient who has been declared brain dead and is sent to the operating room for organ donation.E: Any patient who needs emergency surgery is included in this category.It is possible that patients with any of these 6 classes mentioned above may be candidates for emergency surgery, in which case the extension of emergency will be added to this patient's class.

Exclusion criteria

Exclusion criteria: - Age over 60 years- Requires cataract surgery based on the diagnosis of a specialist doctor- Entry of people with controlled blood pressure (119)Glaucoma in the eye- According to the classification system of the American Society of Anesthesiologists (ASA), the patient should be classified as PS2. The American Society of Anesthesiology classifies patients into 6 classes based on their physical condition and independent of the surgical method: PS1: Patients with normal health who do not have any systemic problems such as cardiac, vascular, respiratory, endocrine, etc. PS2: A person who has a mild systemic disease and the disease is under control and has not created any restrictions for the patient. PS3: A person who has a severe systemic disease and functional limitations have been created for him. PS4: A disease that has a severe systemic disease and puts the person's life at risk. PS5: A patient who is dying and is not expected to survive without surgery. PS6: A patient who has been declared brain dead and is sent to the operating room for organ donation.E: Any patient who needs emergency surgery is included in this category.It is possible that patients with any of these 6 classes mentioned above may be candidates for emergency surgery, in which case the extension of emergency will be added to this patient's class.

Design outcomes

Primary

MeasureTime frame
Hemodynamic status including systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation, breathing rate and intraocular pressure (IOP), duration of intubation, total duration of surgery and length of stay in recovery in the group. Timepoint: Changes are measured before airway device placement, immediately and 5 minutes after device placement, and finally in the recovery room. Method of measurement: Hemodynamic status includes systolic and diastolic blood pressure, heart rate, arterial blood oxygen saturation (SPO2) and cardiac rhythm are monitored by the device. In addition to them, intraocular pressure (IOP) will also be evaluated by a tonometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAkram Arabi

Shahroud University of Medical Sciences

arabi.akram.55@gmail.com+98 23 3239 5054

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026