NCT07045870

Brief Summary

this study aims to compare between effects of lidocaine and ketamine infusion on postoperative analgesia in patients undergoing thyroidectomy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

June 21, 2025

Last Update Submit

July 7, 2025

Conditions

Thyroid Disorder

Outcome Measures

Primary Outcomes (1)

  • the effect of perioperative intravenous lidocaine and ketamine infusion for postoperative analgesia in patients undergoing thyroidectomy

    postoperative pain by Numerical Rating Scale (NRS) Zero means no pain and ten means worst pain

    24 hours posftoperative

Study Arms (3)

group L : will receive lidocaine

ACTIVE COMPARATOR

lidocaine Infusion will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy

Drug: group L : will receive lidocaine

group k : will receive ketamine

ACTIVE COMPARATOR

Ketamine Infusion will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy

Drug: group k : will receive Ketamine

group c: will receive .9% saline

PLACEBO COMPARATOR

.9% saline will be given for Postoperative Analgesia in Patients Undergoing Thyroidectomy

Drug: group c: will recieve .9% saline

Interventions

group L : will receive lidocaineDRUG

group L : will receive 1.5 mg/kg bolus of iv lidocaine 10 minutes before anaesthesia induction then continuous iv infusion rate 1.5 mg / kg / h

group L : will receive lidocaine
group k : will receive KetamineDRUG

patients will receive .25 mg / kg bolus of iv ketamine 10 minutes before anaesthesia induction then continuous iv infusion of ketamine at .25 mg /kg /h

group k : will receive ketamine
group c: will recieve .9% salineDRUG

group c will be injected with equivalent volumes and rates of .9% saline using the same application scheme as the lidocaine and ketamine as a control group

group c: will receive .9% saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18 to 75 years old
  • both sexes
  • scheduled for thyroidectomy

You may not qualify if:

  • toxic goiter
  • (BMI) exceeding 30 kg / m2
  • un controlled hypertension
  • sever liver or kidney disorders
  • allergy to study drugs
  • hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

  • Ludwig B, Ludwig M, Dziekiewicz A, Mikula A, Cisek J, Biernat S, Kaliszewski K. Modern Surgical Techniques of Thyroidectomy and Advances in the Prevention and Treatment of Perioperative Complications. Cancers (Basel). 2023 May 26;15(11):2931. doi: 10.3390/cancers15112931.

    PMID: 37296896BACKGROUND

  • Javidi S, Sadrizadeh S, Sadrizadeh A, Bonakdaran S, Jarahi L. Postoperative complications and long-term outcomes after total and subtotal thyroidectomy: a retrospective study. Sci Rep. 2025 Jan 29;15(1):3705. doi: 10.1038/s41598-024-79860-8.

    PMID: 39881145BACKGROUND

  • Jain SN, Lamture Y, Krishna M. Enhanced Recovery After Surgery: Exploring the Advances and Strategies. Cureus. 2023 Oct 17;15(10):e47237. doi: 10.7759/cureus.47237. eCollection 2023 Oct.

    PMID: 38022245BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Mario N Ishak, Resident

CONTACT

01210609798marionashaat63@gmail.com

Abdel Rahman H Abdel Rahman, Professor

CONTACT

01120320258

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Anasethesia, Surgical Icu, Pain management Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

June 21, 2025

First Posted

July 1, 2025

Study Start

June 11, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations

EG(1)