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Recruiting NCT07510542

Comparison of Stress Response Evoked by Conventional Versus Videolaryngoscope

No phase Interventional Laryngoscopy Stress Response Duration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endotracheal Intubation through a Video Laryngoscope (VL), Endotracheal Intubation through a Direct Laryngoscope (DL).
Who it may be relevant to
Registry conditions: Laryngoscopy, Stress Response, Duration. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Efficacy of Non-channelled Video Laryngoscopy Versus Direct Laryngoscopy in Terms of Stress Response and Intubation Time: a Single-blinded Randomized Controlled Trial

Overview

Impact of using video laryngoscopy versus direct laryngoscopy technique in terms of improved hemodynamics post intubation and time taken for intubation.

Detailed description

The research will be conducted as a single-blind study involving patients undergoing elective surgical processes that necessitate endotracheal intubation. Informed consent will be obtained from all patients. Participants will be randomly assigned through a computer-generated sequence number to either the DL (direct laryngoscopy) group or the VL (video laryngoscopy) group. Monitoring will include vital signs and measurements such as non-invasive blood pressure (NIBP), electrocardiography (ECG), and pulse oximetry (SpO2). Prior to the induction of anesthesia, each patient will undergo assessments including oxygen saturation, blood pressure, echocardiography, systolic, diastolic, and mean blood pressure, heart rate, and oxygen saturation. In addition to the stated observations, the same assessments will be done after one minute of induction, after three minutes of bag-mask ventilation, and one, three, and five minutes after intubation. The time taken to perform endotracheal intubation will also be noted for both direct laryngoscopy and video laryngoscopy. All subjects will be premedicated with Inj. midazolam 0.03 mg/kg. For all patients, the same general anesthesia protocol will be applied, with patients preoxygenated with 100% oxygen for three minutes prior to induction, which will be done with Inj. Nalbuphine 0.15 mg/kg and Inj. propofol 2 mg/kg I.V. After evaluating bag-mask ventilation, Inj. Atracurium at 0.6 mg/kg I.V. will be administered, and isoflurane at 1.2% (1 MAC) will be initiated. After three minutes of bag-mask ventilation, intubation will be performed using either direct laryngoscopy or a non-channelled video laryngoscope, and the time taken for laryngoscopy and intubation will be recorded. Based on the groups, one of the two methods will be utilized to insert the appropriate endotracheal tube. In Group A, endotracheal intubation will be conducted using an indirect non-channelled VL. In Group B, endotracheal intubation will be performed using DL. The placement of the tube will be verified through capnography and chest auscultation before it is secured in position.

Group A The intubation process will utilize the Besdata (BD-M7) Portable VL, which is an indirect laryngoscope without a channel. The investigator will use a curved rigid stylet that is pre-shaped to match the laryngoscope blade, allowing for intubation with either a size 3 or 4 blade. In this research, the time taken for intubation will be recorded using an external timer. This involves measuring the interval from when the blade is inserted into the patient's mouth to the detection of the first capnography wave, while simultaneously using the timer to monitor vital parameters.

Group B Endotracheal tube (ETT) insertion via DL with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group A.

Laryngoscopy in both groups will be conducted by an anesthetist with a minimum of five years of experience in anesthesia practice, ensuring the provision of high-quality care across both groups.

Data Analysis: The data collected will be analyzed via the SPSS software package v.26.0. Numerical variables will be presented as means (standard deviations) for normally distributed variables and as medians (IQRs) for non-normally distributed variables. For categorical variables (as frequencies), and group comparisons between numerical and categorical variables will be performed via the unpaired t-tests and the chi-square tests, respectively.

A p-value \< 0.05 will be considered statistically significant.

Interventions

  • Device Endotracheal Intubation through a Video Laryngoscope (VL)
    In this group, endotracheal intubation will be done through a video laryngoscope
  • Device Endotracheal Intubation through a Direct Laryngoscope (DL)
    In this group, endotracheal intubation will be done through a direct laryngoscope

Primary outcome measures

  • Heart rate [Time frame: Perioperative]
  • Systolic Blood Pressure [Time frame: Perioperative]
  • Diastolic Blood Pressure [Time frame: Perioperative]
  • Mean Blood Pressure [Time frame: Perioperative]
Secondary outcome measures (1)
  • Duration of Laryngoscopy [Time frame: Perioperative]

Eligibility criteria

Inclusion criteria

  • ASA I \& II
  • Age 18-60 years.
  • Preoperatively nonhypertensive and hemodynamically stable patients
  • Patients scheduled for elective procedures not involving airway surgeries
  • Patients with informed consent
  • Mallampati score I and II
  • Interincisor gap > 3 cms
  • BMI less than 30 kg/m²

Exclusion criteria

  • Patient refusal
  • ASA III, IV \& V
  • Hemodynamically unstable patients
  • Patients with Hypertension and Ischemic Heart Disease (whether controlled or uncontrolled)
  • Airway abnormalities, including congenital airway malformations \& maxillofacial abnormalities
  • Head, neck or any facial traumas or history of prior head, neck or airway surgeries
  • Emergency procedures
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Sindh Institute of Urology and Transplantation — Karachi

Identifiers

NCT: NCT07510542 · SIUT-ERC-2026/A-629 · SIUT-ERC-2026/A-629

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗