Comparison of Stress Response Evoked by Conventional Versus Videolaryngoscope

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

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

Study Overview

• Status: Recruiting
• Conditions: Stress Response; Laryngoscopy; Duration
• Intervention / Treatment: Device: Endotracheal Intubation through a Video Laryngoscope (VL); Device: Endotracheal Intubation through a Direct Laryngoscope (DL)

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syed M Abbas, FCPS; Phone Number: 2193 02199215718; Email: smabbas1969@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Recruiting
      • Sindh Institute of Urology and Transplantation
      • Contact: Syed M Abbas, FCPS; Phone Number: +923331318838; Email: smabbas69@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video Laryngoscope (VL); The intubation process will utilize the Besdata (BD-M7) Portable Video Laryngoscope (VL), which is an indirect laryngoscope without a channel. We 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.	Device: Endotracheal Intubation through a Video Laryngoscope (VL); In this group, endotracheal intubation will be done through a video laryngoscope
Active Comparator: Direct Laryngoscope (DL); Endotracheal tube (ETT) insertion via Direct Laryngoscope (DL) with a blade size of either 3 or 4 in the patients; the same external timer will be used as for group VL. Laryngoscopy in both groups will be conducted by an anaesthetist with a minimum of five years of experience in anaesthesia practice, ensuring the provision of high-quality care across both groups.	Device: Endotracheal Intubation through a Direct Laryngoscope (DL); In this group, endotracheal intubation will be done through a direct laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be monitored through a 3-lead ECG monitor	Perioperative
Systolic Blood Pressure	Systolic Blood Pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.	Perioperative
Diastolic Blood Pressure	Diastolic blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.	Perioperative
Mean Blood Pressure	Mean blood pressure will be monitored via a non-invasive blood pressure monitor with an appropriate BP cuff attached to any arm of the patient.	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Laryngoscopy	The time taken to perform endotracheal intubation will also be noted for both direct laryngoscopy and video laryngoscopy. This involves measuring the interval from when the laryngoscope 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.	Perioperative

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Principal Investigator: Syed M Abbas, Sindh Institute of Urology and Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): September 5, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Laryngoscopy; Video laryngoscope; Stress response
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID Numbers: SIUT-ERC-2026/A-629 (Other Identifier: Sindh Institute of Urology and Transplantation, Pakistan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No