A pilot study comparing routine mild sedation with midazolam versus no routine sedation during spinal anaesthesia placement for elective lower-limb orthopaedic surgery
| ISRCTN | ISRCTN17544940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17544940 |
| Sponsor | Cappagh National Orthopaedic Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 26/05/2026
- Registration date
- 28/05/2026
- Last edited
- 27/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
When you have a spinal anaesthetic for leg or hip surgery, the anaesthetist puts a needle in your lower back while you are awake. Some anaesthetists give a small dose of a calming medicine (called midazolam) through a drip before this happens, to help you feel less worried. Other anaesthetists do not give calming medicine and instead offer comfort measures such as music and reassurance.
Both approaches are used every day in hospitals and both are safe. Right now, we do not know which approach patients prefer. We are doing this study to find out whether it is practical to run a bigger study comparing these two approaches, and to get early information about how satisfied patients are with their experience.
Who can participate?
Patients aged 18 or older who are having planned leg or hip surgery under a spinal anaesthetic
What does the study involve?
At your pre-assessment clinic visit, the research team will give you this leaflet and explain the study. You will have time to read it at home and think about it before your surgery day. Before you go to theatre, a member of the research team will see you on the ward, answer any questions, and ask you to sign a consent form if you are happy to take part. You will then answer a few short questions (about 5 minutes) about how you are feeling.
You will be placed into one of two groups by chance (like flipping a coin). Neither you nor the research team can choose which group you go into.
Group A (no calming medicine): You will not be given calming medicine during the spinal needle placement. The anaesthetist will offer you music through headphones and will talk you through what is happening.
Group B (calming medicine): You will be given a small dose of calming medicine (midazolam) through your drip during the spinal needle placement. You will also be offered music and reassurance.
Whichever group you are in, you can ask for calming medicine at any time and you will receive it. Your comfort and safety always come first. The spinal anaesthetic itself is exactly the same in both groups. The only difference is whether you receive calming medicine while the needle is being placed.
In the recovery room (about 1 to 2 hours later), you will be asked two quick questions about your comfort during the needle placement. This takes about 1 minute.
The next day on the ward, you will be asked a few more questions about how satisfied you were and what you remember. This takes about 5 to 8 minutes. That is everything. There are no extra visits, blood tests, or scans. Your surgery and recovery carry on as normal.
What are the possible benefits and risks of participating?
Taking part will not directly help you. However, what we learn may help us give better care to future patients having spinal anaesthetics.
The risks of taking part are very small. Both approaches used in this study are part of normal hospital care.
If you are in the group that receives calming medicine (midazolam), there is a small chance you might feel a bit sleepy or lightheaded. These effects are mild and do not last long. Your anaesthetist watches you closely throughout.
If you are in the group that does not receive calming medicine, you might feel more nervous during the needle placement. But you can ask for calming medicine at any time if you feel you need it.
There is a very small chance that someone could work out who you are from the study data. We take great care to prevent this.
Both approaches in this study are part of normal care, so the chance of something going wrong because of the study is very small. All researchers are covered by the Clinical Indemnity Scheme, which is the State insurance for hospital staff.
Where is the study run from?
Cappagh National Orthopaedic Hospital (Ireland)
When is the study starting and how long is it expected to run for?
April 2026 to April 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Alyssa Kaplan, alyssa.kaplan@nohc.ie
Contact information
Public, Principal investigator
National Orthopaedic Hospital Cappagh
Cappagh Rd, Cappoge, Dublin 11
Dublin
D11 EV29
Ireland
| Phone | +353 (01) 814 0400 |
|---|---|
| alyssa.kaplan@nohc.ie |
Scientific
National Orthopaedic Hospital Cappagh
Cappagh Rd, Cappoge, Dublin 11
Dublin
D11 EV29
Ireland
| Phone | +353 (01) 814 0400 |
|---|---|
| omar.tujjar@nohc.ie |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Routine versus selective intravenous midazolam during spinal anaesthesia needling for elective lower-limb orthopaedic surgery: a single-centre pilot randomised trial (MIND-SPIN Pilot) |
| Study acronym | MIND-SPIN Pilot |
| Study objectives | The primary objective of this pilot randomised trial is to determine the feasibility of a definitive randomised controlled trial comparing routine low-dose midazolam versus no routine sedation during spinal anaesthesia placement for elective lower-limb orthopaedic surgery. Secondary objectives are to obtain preliminary estimates of patient satisfaction, procedural distress, recollection and safety outcomes, and to assess the suitability of candidate satisfaction instruments for the definitive trial. |
| Ethics approval(s) |
Approved 30/03/2026, National Orthopedic Hospital Cappagh Research Ethics Committee (Cappagh Road, Finglas, Dublin 11, Dublin, D11 EV29, Ireland; +353 18140461; Mary.Byrne@nohc.ie), ref: NOHC-2026-ETH-MB-CEO-393 |
| Health condition(s) or problem(s) studied | Procedural sedation in patients undergoing elective lower limb surgery under spinal anaesthesia |
| Intervention | Participants were randomised in a 1:1 ratio, stratified by age younger than 70 years versus 70 years or older, using random permuted blocks of variable size prepared in advance by an investigator not involved in recruitment. Allocation was held in sequentially numbered, opaque, sealed envelopes. The envelope was opened in the operating theatre by the attending anaesthetist before spinal needle insertion. Participants and clinical staff were not blinded to allocation because the intervention could not be concealed in routine clinical practice. Participants undergoing elective lower-limb orthopaedic surgery under spinal anaesthesia were randomised 1:1 to either: Arm A: No routine sedation during spinal anaesthesia placement. Arm B: Routine mild anxiolysis during spinal anaesthesia placement using intravenous midazolam administered in 0.5–1 mg increments with a maximum dose of 3 mg before completion of intrathecal injection. All participants received standard monitoring and standardised non-pharmacological comfort measures. Rescue sedation with intravenous midazolam was permitted in both groups according to predefined criteria, including patient request, significant distress, procedural difficulty, or safety concerns. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Midazolam |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 67 |
| Key inclusion criteria | 1. Adults aged 18 years or older 2. Scheduled for elective lower-limb orthopaedic surgery under spinal anaesthesia as the primary anaesthetic technique 3. American Society of Anesthesiologists (ASA) physical status I–III 4. Able to provide written informed consent 5. Able to complete study questionnaires in the validated study language |
| Key exclusion criteria | 1. Cases with planned general anaesthesia in combination with spinal anaesthesia from the outset 2. Known contraindication or documented hypersensitivity to benzodiazepines 3. Known history of severe paradoxical reaction to benzodiazepines 4. Severe cognitive, linguistic, or sensory communication barriers preventing valid questionnaire completion 5. Clinical situations where the attending anaesthetist determines that sedation is mandatory for patient safety prior to randomisation 6. Participation in another interventional clinical trial that may affect the outcomes of this study. Exclusion criteria are intentionally limited to preserve the pragmatic nature of the trial and to ensure that the pilot population is representative of the population that will be enrolled in the definitive trial. |
| Date of first enrolment | 07/04/2026 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
27/05/2026: Study's existence confirmed by the National Orthopedic Hospital Cappagh Research Ethics Committee.
