Lignocaine Versus Sodium Bicarbonate on Reducing Pain During Propofol Injection

NCT05486819 | Completed Early Phase 1

• 1 other identifier: Pain during propofol injection
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of adding lignocaine and sodium bicarbonate to propofol in reducing pain on propofol injection (POPI).

Conditions

Propofol Adverse Reaction

Keywords

lignocaine,sodium bicarbonate,pain on propofol injection

Outcome Measures

Primary Outcomes (1)

• measuring the pain intensity immediately after intravenous injection of propofol using the four point verbal rating

  5 months

Secondary Outcomes (1)

• 1. Pain intensity at any top up doses of propofol. 2. Heart rate: baseline, 5 seconds, 1 minute & 5 minutes after injection. 3. Blood pressure: baseline, immediately after assessing the pain score then 5 minutes later

  5 months

Study Arms (3)

Group (L)

ACTIVE COMPARATOR

receive 3 ml (60 mg) of lignocaine 2% added to propofol during injection

Drug: Propofol Injection

Group (B)

ACTIVE COMPARATOR

receive 3 ml of sodium bicarbonate 8.5% added to propofol during injection

Drug: Propofol Injection

Group (S)

PLACEBO COMPARATOR

receive 3 ml of normal saline added to propofol during injection

Drug: Propofol Injection

Interventions

Propofol Injection DRUG

adding lignocaine or sodium bicarbonate to propofol to reduce pain during injection

Group (B); Group (L); Group (S)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 65 years old.
• Patients classified as ASA I or II.

You may not qualify if:

• Patients with the history of allergy to propofol or lignocaine.
• Patients took any medication for analgesia or sedation in the past 24 hours.
• Body mass index (BMI) more than 30.
• Patients classified as ASA III \& IV.
• Severe mental illness.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine- Cairo University

Cairo, 11956, Egypt

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia , surgical icu and pain management

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 1, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)