Comparison of effects of two drugs on intracranial pressure in adults undergoing elective laparoscopic and robotic surgery

Effects of intravenous Magnesium sulphate and lignocaine on intracranial pressure in adults undergoing elective laparoscopic and robotic surgery in trendelenberg position - A randomised control trial - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075369

Enrollment

108

Registered

2024-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Inj magnesium sulphate and Inj Lignocaine: Continuous infusion of Inj Magnesium sulphate 10mg/kg/hr or Inj Lignocaine 1.5mg/kg/hr till the end of surgery. Control Intervention1: 0.9% No

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status 1 and 2, between 18-65 years scheduled to undergo laparoscopic and Robotic surgery in trendelenburg position.

Exclusion criteria

Exclusion criteria: H/O neurological illness / surgery Glaucoma or ophthalmic disease other than myopia and hypermetropia Acute or chronic ocular infection Allergy to study drugs Antihypertensives on calcium channel blockers Serum creatinine more than 2.0 mg/dl Surgical procedure duration requiring more than 6 hour

Design outcomes

Primary

Measure	Time frame
To Compare Optic Nerve Sheath Diameter among the groups receiving magnesium sulphate, lignocaine and 0.9% normal saline in patient undergoing elective laparoscopic and robotic surgeryTimepoint: Tb: after induction T1:after giving Trendelenberg position T2: after 1 hour of trendelenburg position T3: every one hourly Te: at the end of surgery during the closure of ports.	—

Secondary

Measure	Time frame
To compare the neuromuscular recovery among the groups To compare the time to first analgesia after surgery among the groups To compare the intraoperative fentanyl requirement among the groups Timepoint: Neuromuscular recovery time(Tnr) :measured at the baseline ( point where the train-of-four ratio (TOFr) reaches 0.9 after the administration of reversal agent) Time to first analgesia after surgery(Tfas) :measured at the baseline ( point of administration of initial dose of analgesic medication to the patient after transfer from the Post-Anesthesia Care Unit (PACU).)	—

Measure

Time frame

To compare the neuromuscular recovery among the groups To compare the time to first analgesia after surgery among the groups To compare the intraoperative fentanyl requirement among the groups Timepoint: Neuromuscular recovery time(Tnr) :measured at the baseline ( point where the train-of-four ratio (TOFr) reaches 0.9 after the administration of reversal agent) Time to first analgesia after surgery(Tfas) :measured at the baseline ( point of administration of initial dose of analgesic medication to the patient after transfer from the Post-Anesthesia Care Unit (PACU).)

—

Countries

India

Contacts

Public ContactDr Senthilnathan M

Jawaharlal Institute of Postgraduate Medical Education and Research

ranjithkumar.kmc@gmail.com9487120564

Outcome results

None listed

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